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15th December 2017
Cancer Research UK has announced the signing of a five-year drug-discovery collaboration between its subsidiary, Cancer Research Technology (CRT), and Celgene Corporation, to discover, develop and commercialise new anti-cancer treatments.
This arrangement represents an expansion of Cancer Research Technology’s theme-based translational model that now encompasses six industry partnerships, including this new collaboration with Celgene.
The collaboration is centred on mRNA translation, the cellular process of assembling proteins, which is a promising area of research with the potential to produce treatments that can target a fundamental characteristic of cancer cells.
Dr Iain Foulkes, Cancer Research Technology’s CEO, said: “This bold and exciting collaboration between one of industry’s leading innovators, Celgene, and CRT is part of our theme-based drug discovery approach and helps leverage our understanding of cancer biology and the needs of patients to drive the most promising discoveries into the clinic.
“This is our largest drug discovery collaboration to date and represents a major endorsement of the reputation and scale of our capacity and expertise in both drug discovery and clinical development by a leading industry partner.”
Cancer Research Technology will lead drug discovery R&D activity and can progress clinical candidates through Phase I trials.
Under the terms of the agreement, Celgene will pay an upfront fee to Cancer Research Technology, and have the option to secure US rights to projects resulting from the collaboration, subject to the payment of additional option fees. Celgene will also have the option to secure Global rights to such projects at the end of phase one clinical trials, subject to the payment of additional option fees.
Cancer Research Technology can receive downstream royalties and development milestones from licensed programs.
13th December 2017
Eisai Europe Limited has announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for the use of Kisplyx® (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy, if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1, and the company provides lenvatinib with the discount agreed in the patient access scheme.1
Lenvatinib is indicated in the European Union in combination with everolimus for the treatment of adult patients with advanced RCC following one prior vascular endothelial growth factor (VEGF)-targeted therapy.2
“We are delighted that NICE is recommending lenvatinib in combination with everolimus for routine access to adult patients for the treatment of advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. RCC is difficult to treat and patients therefore need effective alternative treatment options when their disease progresses,” commented Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai. “We look forward to a further recommendation by NICE for lenvatinib in early 2018 for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI), as this is long overdue and patients have had to wait for almost 3 years already.”
RCC is the most common type of kidney cancer in adults, with over 80% of kidney cancer patients in the UK diagnosed with this type.3 It has the highest mortality rate of the genitourinary cancers, as more than a third of patients with RCC will die from the disease.4
“This is tremendous news for people with advanced renal cell carcinoma. We have been eagerly awaiting this news from NICE for many months. It will be a great relief to patients and their families to know that their clinicians now have the lenvatinib plus everolimus combination as an effective treatment option in the second line,” commented Rose Woodward, Founder and Patient Advocate, Kidney Cancer Support Network. “Kidney cancer is a desperately difficult cancer to treat, and NHS patients need to be confident they can access the latest treatments when they need them. The kidney cancer community is especially grateful that NICE and Eisai have worked together to ensure patients have access to this new clinically effective drug combination.”
The decision by NICE is based on data from study 205, a randomised trial of 153 advanced RCC patients who had progressed after one previous VEGF therapy.5 The results showed that there are significant differences in efficacy between the combination of lenvatinib and everolimus and everolimus monotherapy. When treated with lenvatinib in combination with everolimus (n=51), patients experienced a median progression-free survival (PFS) of 14.6 months compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24–0.68; p=0.0005; investigator assessment).4 Median overall survival (OS) in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group in two update analyses (HR 0.51; 95% CI: 0.30–0.88; p=0.024 and HR 0.59; 95%CI: 0.36–0.97).6
For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) were diarrhoea, decreased appetite and fatigue.5 The most common TEAEs of Grade 3 or higher in the combination arm were diarrhoea, fatigue and hypertension.5
Almost 332,000 people living in the UK will needlessly lose their lives to bowel cancer – a preventable, treatable and curable disease – between now and 2035 unless urgent action is taken to fill critical research gaps identified in a Bowel Cancer UK report ‘Finding the Key to the Cures: a plan to end bowel cancer by 2050’ launched today. If ignored, the scale of the issue will only grow larger.
The research has been published in the leading international academic journal, Gut.
Bowel cancer is the UK’s second biggest cancer killer with 16,000 people dying from the disease, and the fourth most common cancer with over 41,200 people diagnosed each year. Globally, 694,000 people die from bowel cancer and 1.4 million people are diagnosed every year.
Early diagnosis is critical to changing this, but the disease can be difficult to detect early, as symptoms are often attributed to more common, but less serious, conditions. Nearly 98% of people will survive bowel cancer for five years or more if detected at stage 1 compared with less than one in ten people who are diagnosed at stage 4.
To accelerate progress, the charity brought together 100 leading scientists, healthcare professionals and people affected by the disease to identify the key research gaps and priorities in bowel cancer research. If these are addressed, they could transform survival rates and ultimately benefit thousands of people in the future.
The report reveals fifteen key research questions together with vital recommendations to address these gaps, which include:
Professor Mark Lawler, Lead author and Chair in Translational Cancer Genomics, Centre for Cancer Research and Cell Biology, Queen’s University Belfast, says: “This report provides us with a unique road map for bowel cancer research to make an impact, informing and influencing future research ideas, underpinning appropriate research strategies and directing funding allocation to where it is most clearly needed. We have identified the key research priorities that have the greatest potential to benefit patients over the next five years and beyond.”
“This landmark report is the step change needed to energise the research community to stop this deadly disease in its tracks.”
Deborah Alsina MBE, Chief Executive of Bowel Cancer UK, says: “The harsh reality is that every year 16,000 people lose their lives to the disease, and if left unchecked, this number will only increase in the future. The need for speed prompted us to take action to identify a plan to accelerate bowel cancer research.
“This report will act as a catalyst to encourage much needed collaboration, build research capacity and help shape the future of bowel cancer research. Through strategic investment in targeted research, we will deliver improvements for bowel cancer patients.
“By 2028 we want to see the number of people surviving for at least five years to increase from 60% to 75%, this means thousands more people surviving bowel cancer each year. This will take us one step closer to our long term goal, that by 2050 no one dies of bowel cancer.
“Research is the key to finding the cures to bowel cancer.”
Bial and Eisai have announced new real-world audit data presented at the American Epilepsy Society (AES) Annual Meeting 2017, which add to the existing clinical trials examining the effectiveness and tolerability of Zebinix® (eslicarbazepine acetate).
These data assess the real-world effectiveness, safety and tolerability of eslicarbazepine acetate when used as monotherapy in patients with partial-onset seizures, following conversion from previous treatment with carbamazepine or oxcarbazepine and when treated with ≤1200 or >1200mg/day eslicarbazepine acetate.1,2,3
Euro-Esli, an exploratory pooled analysis of data from 14 European clinical practice studies including 2058 patients aged 14-88 years old with partial-onset seizures (POS), with or without secondary generalization, examined the real world use of eslicarbazepine acetate as monotherapy, as well as adjunctive therapy, for POS in clinical practice.
“Euro-Esli study offered data of >200 patients with eslicarbazepine acetate in monotherapy, where it proved to be an effective and tolerable option,” says Dr Vicente Villanueva, Neurologist and Epileptologist, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
The Euro-Esli study also showed that eslicarbazepine acetate was efficacious and generally well tolerated in patients switching from carbamazepine or oxcarbazepine in clinical practice.1 A further abstract, examining a different Euro-Esli data set, explored the effectiveness, safety and tolerability of eslicarbazepine acetate in patients with partial-onset seizures treated with ≤1200 or >1200mg/day.2
Epilepsy is one of the most common neurological conditions in the world, affecting approximately fifty million people in Europe.4 It is defined as either: (1) the occurrence of two or more unprovoked seizures >24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures; (3) diagnosis of an epilepsy syndrome.5 Depending on the type, seizures may involve one part of the body or the whole body, and may affect consciousness. Epilepsy has many possible causes but sometimes the cause is unknown.6
“Real-world data explores the impact of a treatment in a real-life environment and these data improve our knowledge and understanding around the use of eslicarbazepine acetate, reinforcing Bial’s commitment to developing and delivering beneficial treatment options for people living with epilepsy” comments António Portela, CEO of Bial.
“We are committed to the development of our anti-epileptic drug product portfolio, and Eisai continues to invest in real world evidence which will help us ensure we are addressing the diversity of epilepsy patients, which may help improve their quality of life,” comments Neil West, Vice President EMEA, Global Neurology Business Unit at Eisai.
In Europe eslicarbazepine acetate is indicated as:
Sobi and Bioverativ Inc have announced the results of a new, post-hoc, longitudinal analysis of the pivotal Phase III A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy Elocta® (efmoroctocog alfa) has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals.
Elocta was developed using Fc fusion technology to prolong circulation in the body and its efficacy and safety have been studied in haemophilia A patients since 2010. This new, post-hoc analysis supports a growing body of clinical data showing prophylactic treatment with Elocta can positively impact long-term joint health. Elocta is currently not indicated for weekly dosing.
“One of the challenges for people with severe haemophilia A can be treatment every few days with inadequate bleed protection,” said Maha Radhakrishnan, MD, Senior Vice President of Medical at Bioverativ. “We are committed to improving patient outcomes and continue to explore how Eloctate can meaningfully make a difference for patients with the potential for longer dosing intervals that could provide continued joint health improvement.”
Prophylactic treatment with factor therapy is recognised as the optimal therapy for severe haemophilia A, yet, according to the World Federation of Hemophilia guidelines, this treatment regimen traditionally involves injections three times per week with conventional factor based products. With Elocta’s extended half-life, patients can extend dosing intervals up to five days resulting in less frequent injections. Using data spanning four years from the pivotal Phase III A-LONG study, and ASPIRE, the long-term extension study, researchers examined subjects who were exposed to a seven-day dosing (65 IU/kg/wk) interval to assess long-term outcomes as determined by annualized bleeding rates (ABR), adherence and resolution of target joints.
In the study, 43 adults and adolescents (>12 years) were exposed to an Elocta weekly dosing interval for a median study duration of 3.1 years. Researchers also analysed results of those who maintained a weekly dosing interval throughout the study period (n=19).
For those subjects in the ever-on-weekly dosing group who had pre-study episodic treatment (n=32), transition to weekly prophylaxis dosing resulted in a change in median ABR (IQR) of -23.7 (-35.8, -12.8). For those subjects who were always on a weekly dosing regimen throughout the study period (n=19), the median pre-study ABR (IQR) for subjects on a pre-study episodic regimen was 29 (18, 45) compared to an on-study ABR (IQR) of 1.7 (0.5, 6.7). Subjects experienced protection from spontaneous bleeds (median spontaneous ABR (IQR) of 1.2 (0.2, 2.8) for subjects ever-on-weekly dosing and 0.7 (0, 1.6) for subjects always-on-weekly-dosing and from spontaneous joint bleeds (median ABR (IQR) of 0.8 (0, 2.5) in subjects ever-on-weekly dosing and 0.2 (0, 1.0) in subjects always-on-weekly-dosing).
All subjects were highly adherent while on the weekly dosing regimen (median duration of 3.1 years) and among subjects who chose to initiate a weekly dosing regimen on Elocta at any point of the study, the majority stayed on weekly dosing. One hundred percent of all evaluable target joints in both the ever-on-weekly dosing group and always-on-weekly dosing group resolved during the study period. Study findings suggest weekly dosing may be a reasonable prophylaxis regimen for patients receiving episodic treatment, who would prefer the benefit of prophylaxis and better bleed protection, but with minimal treatment burden.
“Together with Bioverativ, we have long been committed to transforming the care of people with haemophilia through our treatments and ongoing research,” said Armin Reininger, MD, PhD, Head of Medical and Scientific Affairs, Sobi. “These data show the potential of Elocta to make a difference for patients, to be able to extend their dosing intervals based on their needs, with improved joint health, and the possibility to reduce the burden of chronic treatment in patients with haemophilia.”
1st December 2017
Researchers from the University of Southampton have tested different combinations of antibodies in the lab to see how they interact with each other and what effect this has on how the immune system fights cancer.
They found one combination – anti-CD27 and anti-CD20 – greatly increased life expectancy in mice with cancer. While most of the mice given just one of the antibodies died within 80 days, nearly all mice given both antibodies survived beyond 100 days.
When combined, the researchers found the antibodies recruit greater numbers of immune cells called myeloid cells, as well as increasing their ability to destroy cancer cells.
As a direct result of this study, the combination will now be tested in patients as part of a clinical trial funded by Cancer Research UK.
Dr Sean Lim, a Cancer Research UK clinician scientist at the University of Southampton, said: “By combining two specific antibodies – anti-CD27 and anti-CD20 – we’ve increased the ability of the immune system to destroy cancer cells.
“It’s very exciting to see that this drug combination has an impact on survival of mice with lymphoma, as improvements in treatment are urgently needed. The next stage will be to see if what we’ve discovered can be replicated in patients.”
Professor Karen Vousden, Cancer Research UK’s chief scientist, said: “This study greatly increases our understanding of how different immunotherapies can work together to improve the way we treat lymphoma.
“By testing this approach in a clinical trial we will see if this promising research will translate into benefit for patients.”
30th November 2017
Novartis has announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month).1
Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID).2 Treatment with erenumab was well tolerated, with a safety profile comparable to placebo. Erenumab is the first and only fully human monoclonal antibody of its kind, designed to specifically block the CGRP receptor, which plays a critical role in migraine activation.
STRIVE enrolled 955 patients, who were randomized to receive either placebo or subcutaneous erenumab 70mg or 140mg once a month,for six months. Patients taking erenumab at the higher dose experienced a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days (3.2-day reduction with 70mg, 1.8-day reduction with placebo, both p<0.001). Fifty percent of patients taking erenumab 140mg had their migraine days cut by at least half, representing a significantly higher likelihood of achieving this response compared to placebo (43.3% with 70mg; 26.6% with placebo, both p<0.001; odds ratios of 2.8 and 2.1 respectively for 140mg and 70mg). STRIVE endpoints were assessed from baseline to the average of the last three months (months 4, 5, 6).
Principal Investigator, Peter Goadsby, MD, PhD, FAHS, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College Hospital, London, shared his view on what the findings could mean for those with migraine, “STRIVE is the first fully reported phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine,” Prof. Goadsby said, “The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.”
“The results of the STRIVE study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. “People with migraine are missing out due to this debilitating neurological disease and are in need of safe, tolerable and effective preventive treatments. We are committed to bringing this much-needed treatment option to patients as soon as possible.”
Other secondary endpoint results from the study include:
In STRIVE, more than 90% of patients taking erenumab completed the study. Adverse reactions leading to discontinuation of treatment occurred in 2.2% of erenumab-treated patients and in 2.5% of patients receiving placebo. STRIVE contributes to an extensive body of evidence in support of the efficacy, safety and tolerability profile of erenumab, including four placebo-controlled Phase II and Phase III clinical studies involving more than 2600 patients, as well as an ongoing open-label extension up to five years in duration.
Erenumab is the first investigational therapy targeting the CGRP pathway to have received FDA and EMA regulatory filing acceptance to date. The STRIVE study is one of the pivotal trials included in the US and EU regulatory applications under review for erenumab. If approved, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialisation rights to the drug in Japan and Novartis has exclusive rights to commercialise in rest of world.
27th November 2017
Results of a new survey highlight the need for improved education and standardised guidance for oncologists initiating cancer treatment in women who may want to safeguard their fertility.1
While discussing fertility preservation with newly diagnosed cancer patients is a high priority for over two-thirds (70%) of oncologists, almost one in four (24%) are still of the opinion that the success rate of fertility preservation is not yet good enough to make it an available option.1 This seems to be reflected in referral rates, with nearly
one in five cancer patients, who consult IVF clinics, seeking out fertility preservation advice themselves without an oncologist referral.1
Infertility is a possible side effect of some types of cancer treatment.2 This is because chemotherapy and radiotherapy can affect the ovaries, the production of eggs in the ovaries or the womb.3 The only way to help safeguard fertility for these patients is to initiate fertility preservation prior to cancer treatment. Options include egg-freezing, a process where eggs are extracted from the ovaries and frozen for future fertilisation and implementation, and embryo freezing, where the collected eggs are already fertilised with sperm prior to being frozen.4
Teva Pharmaceuticals Europe conducted the survey in order to better understand the oncofertility referral pathway as well as the habits of oncologists and fertility specialists when it comes to discussing this matter with their patients.1 Nearly all (97%) oncologists questioned declared they do inform their patients about the risk of infertility associated with cancer treatment, with 9 in 10 stating they immediately refer at-risk patients to fertility specialists.1
However, interestingly, the survey also revealed that nearly two thirds of fertility specialists are under the impression oncologists do not sufficiently explain and address the issue of fertility after cancer treatment with their patients.1
Another unexpected finding of the survey was that one in five oncologists did not know if there were any national guidelines on fertility preservation for cancer patients.1 Fewer than one-third of the oncologists (31%) said there were national guidelines, compared with 43% of fertility specialists,1 reflecting either a lack of guidelines and/or a lack of awareness of availability of guidelines. However, nearly all healthcare professionals agreed on the need for guidelines, with 89% of oncologists and 92% of fertility specialists saying they were either useful or needed.1
“It’s critical cancer patients of child-bearing age are given the chance to preserve their fertility before starting treatment, and they should expect consistent provision of advice and care,” says Professor Zeev Shoham, Director of the IVF unit, Kaplan Medical Centre, Rehovot, Israel, whose reference portal for fertility specialists, “IVF Worldwide”, played a leading role in the survey. “Oncologists understand the importance of discussing fertility with their patients, but they’re trying to give their patients the best care with varying knowledge and, as seen in the survey, often without being aware of guidelines. These results once again highlight the key need for improved education of oncologists and standardised referral pathways.”
“Teva Pharmaceuticals is dedicated to helping women, who are faced with cancer, focus on getting well, knowing that everything possible is being done to preserve their fertility, if that is their wish,” says Rachel Levy-Toledano, Associate Medical Director Fertility, Teva Pharmaceuticals Europe.
The full results of the survey are expected to be published in the first half of 2018.
17th November 2017
A group of twenty organisations – lead by Health Care Without Harm (HCWH) Europe – have sent a Declaration to European Commissioner for Environment, Maritime Affairs and Fisheries, Karmenu Vella, expressing their deep concern about the threat posed by pharmaceuticals in the environment to European citizens, their communities, and the environment.
The Declaration comes during World Antibiotic Awareness Week and on the eve of European Antibiotic Awareness Day.
The consortium of organisations, which is made up of hospitals, health organisations, professional health and student associations, and health and environment NGOs, wrote to the Commissioner to highlight the importance of introducing ambitious legislation in the upcoming Strategic Approach to Pharmaceuticals in the Environment (due to be released in early 2018).
The Declaration also highlights the unintended consequences of the release of increasing amounts of pharmaceuticals into the environment on both human and environmental health.
Pharmaceuticals in the environment represent a global pollution – over 631 different pharmaceutical agents or their metabolites have been detected in 71 countries on all continents.
The European Union is one of the largest consumers of human medicinal products in the world (24% of the global production), second only to the US Pharmaceutical pollution, however, is an unrestricted cross-border phenomenon that affects all countries.
Active Pharmaceutical Ingredients (APIs, the part of the medicine that is biologically active in order to have an effect on the body) are designed to be biologically active and often remain unchanged during their passage through the body. These APIs can also enter the environment during the production phase (through wastewater) and when medicines are disposed of incorrectly (by flushing down the toilet or sink).
Even low concentrations of pharmaceuticals in the environment can have far-reaching effects on ecosystems – causing reproductive failure, growth inhibition, behavioural changes, and species’ population collapse, such as the near extinction of vultures feeding on animals that have been treated with diclofenac in Pakistan.
As well as outlining the problems associated with pharmaceuticals in the environment, the group also propose solutions in the Declaration, in the form of a comprehensive set of policy recommendations, stating that:
“We, the undersigned, strongly believe that [these] recommendations should be incorporated into the ‘Strategic Approach to Pharmaceuticals in the Environment’. EU citizens have the right to live in a safe environment in order to prevent sickness and the spread of AMR. We therefore call on the European Commission to consider our position on this issue and take immediate action to protect human and environmental health.”
Speaking of the Declaration, HCWH Europe Executive Director Anja Leetz said:
“Pharmaceuticals in the environment are a global pollution problem which needs to be addressed immediately. By allowing this known problem to continue we are running a global experiment with no control group. We do not know enough about the long-term and cumulative cocktail effects of small amounts of pharmaceutical residues in our water and food supply and we need to apply the precautionary principle and reduce exposure where possible. We urgently need to minimise the release of pharmaceuticals into the environment at all stages of their life cycle in order to limit the potential damage to human or environmental health.”
The Declaration is co-signed by:
GlaxoSmithKline and Innoviva, Inc have announced that the European Commission has granted marketing authorisation for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
Trelegy Ellipta is the first once-daily single inhaler triple therapy to be approved in Europe. It is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler. The licensed strength as delivered is FF/UMEC/VI 92/55/2 mcg.
Eric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “COPD is a serious lung disease that affects millions of people. Its progressive nature means symptoms can worsen over time with many patients also experiencing frequent debilitating exacerbations. A combination of different types of medicines can be required to achieve treatment goals. Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation. We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD.”
Mike Aguiar, CEO of Innoviva, Inc. said, “Knowing that appropriate COPD patients will require triple therapy, Trelegy Ellipta affords the convenience of administration of three classes of medicines in a single inhaler. Having all three major classes of combination medication (ICS/LABA, LAMA/LABA, and now single inhaler triple therapy) in the single Ellipta inhaler is an important advance in inhaled therapeutics.”
The first European launch is expected to take place before the end of 2017.