Merck, a leading science and technology company, has today announced that MAVENCLAD® (cladribine tablets) has been approved by the MHRA and is now indicated for the treatment of adult patients in Great Britain with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features.’
Cladribine tablets first received regulatory approval for patients in Great Britain in 2017 for highly active relapsing MS as defined by clinical or imaging features. This approval will expand access for the eligible patient population of cladribine tablets and will provide a new treatment option for these patients.
In Great Britain, it is estimated that there are over 125,000 people living with MS, with an estimated 7,000 individuals newly diagnosed with MS each year. The expanded label would mean that more of these newly diagnosed patients would be eligible for treatment with MAVENCLAD earlier in their disease course.
This approval by the MHRA follows a robust review of the benefit: risk profile of cladribine tablets for this patient group which looked at the current evidence in this population, including data from both pivotal and post-approval studies alongside post-approval adverse event (AE) reporting and concluded that there is a favourable benefit: risk profile to warrant use in this wider population.
Cladribine tablets, are a short-course oral treatment, which can be taken at home, and consists of a maximum of 20 days of treatment in each of years 1 & 2 with no further treatment required in years 3 & 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.
Dr Doina Ionescu, Managing Director of Merck Healthcare UK and Ireland, said:
“It is fantastic news that the MHRA has taken this pioneering decision for patients in Great Britain. It is the first regulator in Europe to approve an expanded label for cladribine tablets to include active RMS, which will broaden patient access to a treatment which just last year was included in the World Health Organisation’s Essential Medicines List.
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.”
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 RMS 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.”
Following the MHRA’s decision, Merck will be urgently seeking reimbursement with a new cost-effectiveness evaluation with NICE and SMC, that if successful, would make cladribine tablets available to more patients in England, Wales, and Scotland.
