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30th January 2024
The new antibiotic combination cefepime/enmetazobactam (brand name Exblifep) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of complicated urinary tract infections (cUTI), its manufacturer Advanz Pharma has announced.
The intravenous formulation is a fixed-dose combination of enmetazobactam – a novel extended-spectrum-lactamase inhibitor belonging to the penicillanic acid sulfone class – with the 4th generation cephalosporin cefepime.
This enhances the efficacy of cefepime against resistant bacteria, including extended spectrum beta-lactamase (ESBL)-producing pathogens.
Cefepime/enmetazobactam has been given the green light in the EU for the treatment of adult patients with cUTIs, including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed.
The drug was designed as a new antibiotic combination to combat the growing antimicrobial resistance in Gram-negative bacteria, Advanz Pharma said.
The CHMP recommendation was based on the results of the phase 3 randomised, double-blind, multi-centre ALLIUM trial, which was undertaken at 112 sites in 19 countries.
The trial considered how the efficacy of cefepime/enmetazobactam compared with piperacillin/tazobactam for the treatment of cUTIs or acute pyelonephritis (AP) and the primary efficacy outcome was clinical cure and microbiological eradication.
Eligible patients were randomised to receive either cefepime, 2 g/enmetazobactam, 0.5 g (n = 520), or piperacillin, 4 g/tazobactam, 0.5 g (n = 521), by two-hour infusion every eight hours for seven days (up to 14 days in patients with a positive blood culture at baseline).
Cefepime/enmetazobactam demonstrated statistically significant superior overall treatment success (clinical cure combined with microbiological eradication) at a test-of-care visit compared with piperacillin/tazobactam in cUTI, including AP, caused by Gram-negative pathogens (79.1% vs 58.9%).
Statistically significantly superior results were also observed among patients with infections caused by ESBL-producing pathogens (73.7% vs 51.5%, respectively).
Cefepime/enmetazobactam demonstrated a tolerable safety profile, comparable to piperacillin/tazobactam.
Treatment-related serious adverse events were reported in 0.2% of patients treated with cefepime/enmetazobactam versus 0.6% of patients treated with piperacillin/tazobactam.
The European Medicines Agency noted the most common side effects as pain and inflammation at the infusion site, diarrhoea, skin rash and headache.
According to Advanz Pharma, cefepime/enmetazobactam has shown promising in vitro activity against the more resistant beta-lactamase mutations OXA-48 and AmpC, which are increasing in Europe and for which there are few therapeutic alternatives.
18th December 2023
Etrasimod (brand name Velsipity) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in eligible patients with ulcerative colitis (UC), its manufacturer Pfizer has announced.
The oral, one-daily selective sphingosine-1-phosphate (S1P) receptor modulator selectively activates S1P receptor subtypes 1, 4 and 5, with no detectable activity on S1P.
It has been given the green light in the EU for the treatment of patients aged 16 years and older with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
If etrasimod were to subsequently be approved by the European Commission, it would represent the first global approval of an oral advanced ulcerative colitis therapy for use in older adolescents.
Velsipity is currently approved in the US, to treat adults with moderately to severely active ulcerative colitis.
Michael Corbo, chief development officer, inflammation and immunology, Pfizer Global Product Development, said: ‘Ulcerative colitis is a chronic condition that affects over 2.6 million people in Europe, and can have a debilitating effect on patients’ lives. If approved, Velsipity could offer patients with moderately to severely active ulcerative colitis the opportunity to achieve steroid-free remission.
‘This positive recommendation is a significant step forward in Pfizer’s efforts to bring this convenient once-daily oral treatment to appropriate patients in the EU affected by ulcerative colitis who require an advanced treatment option with a favourable benefit-risk profile.’
The CHMP positive opinion was based on results from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.
They evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission in ulcerative colitis patients who had previously failed or were intolerant to at least one conventional, biologic or Janus kinase inhibitor therapy.
The coprimary endpoints in ELEVATE UC 52 were the proportion of patients who achieved clinical remission at week 12 (induction period) and week 52 (maintenance period).
The researchers found a significantly greater proportion of patients in the etrasimod group achieved clinical remission compared with patients in the placebo group at completion of the 12-week induction period (74 [27%] of 274 patients vs 10 [7%] of 135 patients) and at week 52 (88 [32%] of 274 patients vs 9 [7%] of 135 patients).
The primary endpoint for ELEVATE UC 12 was the proportion of patients in clinical remission at the end of the 12-week induction period.
Some 55 (25%) of 222 patients in the etrasimod group had clinical remission compared with 17 (15%) of 112 patients in the placebo group at the end of the 12-week induction period.
Both studies also achieved all key secondary efficacy endpoints, with a favourable safety profile consistent with previous studies of etrasimod.
The most common adverse reactions were lymphopenia (11%) and headache (7%).
The drug also demonstrated improvement in the total inflammatory bowel disease questionnaire score, which measures health-related quality of life.
20th October 2023
Rucaparib has been given a positive opinion as a first-line maintenance treatment for patients with advanced ovarian cancer by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), its manufacturer Pharma& has announced.
Suitable for all women with advanced ovarian cancer, regardless of BRCA mutation status, who have responded to first-line platinum-based chemotherapy, rucaparib (brand name Rubraca) is a poly-ADP ribose polymerase (PARP) inhibitor.
The targeted cancer drug is currently approved as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.
The recent recommended approval from the CHMP is a Type II variation on the current license and is based on the randomised, double-blind, placebo-controlled, phase 3 ATHENA-MONO trial results.
The trial demonstrated that rucaparib significantly improved investigator-assessed progression-free survival compared with placebo in women, regardless of their BRCA mutation status in each of the populations studied.
The safety profile observed in the ATHENA-MONO trial was consistent with both the current US and European labels for rucaparib.
Dr Rebecca Kristeleit, consultant medical oncologist and adjunct reader at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, and European Network of Gynaecological Oncological Trial (ENGOT) lead of the ATHENA trial, said: ‘In the ATHENA-MONO trial, rucaparib prolonged progression-free survival, irrespective of molecular characteristics, and its potential approval by the European Medicines Agency as a first-line maintenance treatment is an important step forward in this difficult-to-treat population.
‘Women with advanced ovarian cancer need and deserve new treatment options to improve outcomes, and [this] recommendation is hopeful news for eligible patients in Europe.’
The European Commission will now review the positive opinion and Pharma& anticipates an approval decision in the coming months.
Elmar Zagler, founder and managing director, Pharma&, said: ‘Accessing effective medicines is the primary goal for both healthcare providers and patients, and it can be devastating when these medicines are no longer available.
‘Over the last five years, Pharma& has established itself as an agile, fully integrated global company that aspires to breathe new life into proven medicines like rucaparib.’
Earlier this year, rucaparib was found to improve progression-free survival in metastatic, castration-resistant prostate cancer with BRAC alteration compared to usual care.
14th September 2023
New measures recommending the avoidance of all medicines containing topiramate during pregnancy have been published by the European Medicines Agency‘s Pharmacovigilance Risk Assessment Committee (PRAC).
While it is well known that topiramate can cause major congenital malformations and foetal growth restriction if used during pregnancy, recent data also suggest a potential increased risk of neurodevelopmental disorders after exposure in the womb.
Topiramate-containing medicines are used for the treatment of epilepsy and the prevention of migraine, with some EU countries also using the drug in a fixed-dose combination with phentermine for weight reduction.
For patients using topiramate for the treatment of epilepsy, the latest PRAC recommendations state that the drug should not be used during pregnancy unless there is no other suitable treatment available. This builds on existing advice that topiramate is contraindicated during pregnancy when used for the prevention of migraine or for weight management.
Additional recommendations involve the establishment of a pregnancy prevention programme. This means that healthcare professionals should ensure any woman or girl who is able to have children has been made fully aware of and has understood the risks of taking topiramate during pregnancy, as well as the measures that must be taken.
This includes taking a pregnancy test before starting treatment and the need to avoid becoming pregnant during topiramate treatment by using effective birth control for the treatment duration and for at least four weeks after its cessation.
Alternative treatment options should be considered and the need for topiramate treatment should be reassessed at least annually using a risk awareness form.
The product information for topiramate-containing medicines will be updated to further highlight the risks and the measures to be taken and a visible warning added to the outer packaging of the medicines.
In addition, patients and healthcare professionals in Europe will be provided with educational materials regarding the risks of using topiramate during pregnancy, and a patient card will be provided to the patient with each medicine package.
In spring 2018, the UK’s Medicines and Healthcare products Regulatory Agency banned the use of valproate for epilepsy during pregnancy without a pregnancy prevention programme.
These recommendations from the PRAC were based on the findings from three recent observational studies. In the first, prenatal exposure to topiramate was associated with increased risk of neuro-developmental disorders. The second study showed prenatal topiramate was linked to a greater risk of attention deficit hyperactivity disorder.
The third demonstrated that topiramate use late in pregnancy was associated with twice the risk of neurodevelopmental diagnoses in children compared to unexposed pregnancies.
In its review, the PRAC confirmed the known increased risk of birth defects and reduced growth of the unborn child when mothers receive topiramate during pregnancy. It estimated that birth defects will occur in between four and nine out of every 100 children born to women who take the drug during pregnancy, compared with one to three out of every 100 children to women who do not take topiramate.
In further analysis, the PRAC estimates that 18 in every 100 children were smaller and weighed less than expected at birth to mothers taking topiramate compared to only five in every 100 children born to mothers without epilepsy and not taking anti-epileptic medication.
Also triggered by the first study outlined above, the UK’s Medicines and Healthcare products Regulatory Agency announced in July 2023 that it had started a safety review of topiramate in relation to the potential for neurodevelopmental disorders.
31st August 2023
The total cost of cardiovascular disease (CVD) in the EU reached an estimated €282bn in 2021, according to new research presented at the European Society of Cardiology (ESC) Congress 2023.
Cardiovascular healthcare accounted for €130bn (46%) of the expenditure, while productivity losses associated with absenteeism and retirement due to illness and disability (5%) and premature death (12%) were estimated at €15bn and €32bn, respectively.
This is the first study to use Europe-wide patient registries and surveys rather than relying on assumptions and, for the first time, includes the costs of long-term social care, which accounted for €25bn (9%) of the total.
A wide variation between countries was identified in the proportion of healthcare budgets spent on CVD, ranging from 6% in Denmark to 19% in Hungary.
The total cost of CVD equated to €630 per EU citizen, varying from €381 in Cyprus to €903 in Germany.
A collaboration between the ESC and the UK’s University of Oxford, this was the most comprehensive and up-to-date analysis of the economic costs of CVD to EU society since 2006.
Study author Dr Ramon Luengo-Fernandez, associate professor at the University of Oxford, said: ‘CVD had a significant impact on the EU27 economy, costing a total of €282bn in 2021. That’s equivalent to 2% of Europe’s GDP and is significantly more than the entire EU budget itself [€186.6bn in 2023], used to fund research, agriculture, infrastructure and energy across the Union.’
In the study, healthcare included primary care, emergency care, hospital care, outpatient care and medications, while social care included long-term institutionalised care, and care at home.
The main contributor to the expenditure was hospital care at €79bn, representing 51% of CVD-related care costs, and CVD medications accounted for €31 billion (20%). Residential nursing care home costs totalled €15bn (9%).
Informal care, which includes the work or leisure time, valued in monetary terms, that relatives and friends gave up to provide unpaid care accounted for €79bn (28%) of the costs. The research found 7.5 billion hours of unpaid care were provided by relatives and friends for patients with CVD.
What’s more, million working-days were lost in the EU in 2021 because of CVD illness and disability, while 1.7 million people died due to CVD across the EU, representing 1.3 million working-years lost.
ESC board member and study author Professor Victor Aboyans, head of cardiology at University Hospital Limoges in France, said: ‘This study underscores the urgent need to act collectively on the European scale to better combat the cardiovascular risk of European citizens, in particular through regulations for better cardiovascular prevention and investment in research.
‘By choosing not to invest in cardiovascular disease we are simply deferring the cost. These data force us to ask the question: do we invest in cardiovascular health today or be forced to pay more at a later stage?’
Professor Panos Vardas, chief strategy officer of the European Heart Agency, added: ‘It is evident that there is significant fragmentation among EU countries in terms of cardiovascular disease healthcare expenditures. This necessitates a re-evaluation by the EU as a whole, and the 27 EU countries individually, to better address the outstanding needs and invest more effectively in supporting those suffering from cardiovascular disease.’
13th July 2023
Doctors and other healthcare professionals from the EU can continue to join the NHS workforce for the next five years without taking additional tests, following a recent UK Government review.
The law enabling this, named ‘standstill provisions’, came into effect on the day the UK left the European Union, and the health secretary was required to review it from January 2023 and decide a way forward.
The Department of Health and Social Care (DHSC) concluded that the provisions will remain in place ‘for a temporary period of five years’, meaning EU qualified healthcare professionals can continue to register with their UK regulator without further assessment.
An average of more than 4,000 EU doctors, nurses, midwives, pharmacists, dentists and other healthcare professionals join the NHS annually, according to the DHSC.
The department’s data analysis also showed that while the number of applications from EU professionals was generally lower over the last two years than in 2019, the number has been increasing since 2021, and the doctor and nursing regulators received the most across each year.
A consultation, which included the GMC, found that a majority of stakeholders wanted the standstill provisions to remain ‘in the short-term’ in order to ‘avoid operational issues’ if they ended this year.
The DHSC said retaining the provisions ‘will support the department’s ambition to attract and recruit overseas healthcare professionals, without introducing complex and burdensome registration routes’.
EU doctors and other healthcare professionals may only need to take language skills tests and checks on fitness to practise, where necessary, in order to register with their relevant regulator and work in the NHS.
The Government long-term workforce plan recognises ‘the skills and dedication of staff who have come here from around the world’, it sets out plans to increase the number of home-grown staff with a doubling of medical school places to 15,000 by 2031 to reduce reliance on overseas recruitment.
A version of this story was originally published by our sister publication Pulse.
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