Cladribine tablets (brand name Mavenclad) have been granted a label extension by the Medicines and Healthcare products Regulatory Agency (MHRA) to expand access for additional patient populations with multiple sclerosis (MS), its manufacturer Merck has announced.
It is now indicated for the treatment of adult patients in Great Britain with relapsing forms of MS with active disease as defined by clinical or imaging features.
The expanded label means more newly diagnosed patients will be eligible for treatment with cladribine earlier in their disease course. Since 2017 it has been approved for use in patients with highly active relapsing MS as defined by clinical or imaging features.
Its latest approval makes cladribine the only short-course oral treatment for active relapsing MS available in Europe.
Cladribine tablets, which can be taken at home, are taken for a maximum of 20 treatment days in each of years 1 and 2 with no further treatment required in years 3 and 4.
This low administrative burden can offer advantages to a patient’s quality of life over other types of MS treatment, which can require drugs to be administered via regular self-injections, as an infusion in hospital, or as daily tablets, Merck said.
Speaking about the approval, Dr Wallace Brownlee, consultant neurologist and multiple sclerosis specialist, said: ‘The expansion of the label for cladribine tablets could improve patient outcomes and quality of life for many MS patients with active relapsing MS in Great Britain by allowing us to use cladribine tablets earlier in the treatment pathway.
‘This will be the first high-efficacy oral short-course treatment to be available for this patient group in Europe and could provide clinicians with an additional treatment option which also provides patients with treatment which has a low monitoring and administration burden.’
This approval by the MHRA follows a robust review of the current evidence around the benefit-risk profile of cladribine tablets for this patient group. The pre- and post-approval studies considered in the review included:
- The CLARITY (Cladribine Tablets Treating MS Orally) study
- The CLARITY extension study
- The ORACLE MS (Oral Cladribine in Early MS) study
- The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients with Active Relapsing Disease) study
- The PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study
The review concluded that there is a favourable benefit-risk profile to warrant use in this wider population.
Dr Doina Ionescu, managing director of Merck Healthcare UK and Ireland, said: ‘We know from our long history of working in the field of MS that there is still an unmet need for many patients to have access to a high-efficacy oral treatment which can be used early in the course of the disease.
‘Since the NICE approval in 2017, cladribine tablets have treated globally over 80,000 patients which has been supported by data from both our pivotal studies and real-world evidence we have shared. More patients could benefit from cladribine tablets than before, so we look forward to applying for NHS reimbursement with urgency.’
