Mavenclad now OK’d in UK to also treat active relapsing MS patients

The prescribing label for Mavenclad (cladribine) in Great Britain has been extended to include the treatment of adults with active relapsing forms of multiple sclerosis (MS), as defined by clinical or imaging features.

This decision made the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) the first to expand Mavenclad’s label to include relapsing MS patients with active disease. In the rest of Europe, the therapy remains approved solely for people with highly active disease, also defined by certain clinical or imaging features.

The extended indication means that more patients will have access to Merck‘s disease-modifying therapy in Great Britain — including some individuals who are newly diagnosed and have not received other MS treatments in the past.

Importantly, Mavenclad is one of three MS therapies included in the Model Lists of Essential Medicines (EML) put out by the World Health Organization (WHO), which compiles a listing of medications that are of high priority, safe, and cost-effective, and should be available as part of any functioning healthcare system.

“It is fantastic news that the MHRA has taken this pioneering decision for patients in Great Britain,” Doina Ionescu, managing director of Merck Healthcare UK and Ireland, said in a company press release.

“It is the first regulator in Europe to approve an expanded label for cladribine tablets to include active [relapsing MS], which will broaden patient access to a treatment which just last year was included in the World Health Organisation’s Essential Medicines List,” Ionescu said.

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The approval follows a review of current evidence showing a favorable risk-benefit profile of Mavenclad among people with active relapsing forms of MS. That evidence included data from both clinical trials and post-approval studies, as well as the reporting of adverse events after the therapy was approved.

The company will now be working with the U.K.’s National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium to include Mavenclad in the National Health Services (NHS) of England, Wales, and Scotland, which could make the therapy available to patients at low or no cost.

“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,” Ionescu said.

With this decision “more patients could benefit from cladribine tablets than before, so we look forward to applying for [National Health Service] reimbursement with urgency,” she added.

In MS, the immune system mistakenly attacks the myelin sheath, a protective layer around nerve fibers that helps them send electric signals more efficiently. Damage to myelin prevents nerve signals from being effectively transmitted and can lead to permanent nerve cell damage.

A short-course oral treatment, Mavenclad works by reducing the number of immune B- and T-cells — the main drivers of inflammation and damage in MS. This can significantly reduce the risk of relapses or brain lesions and slow the accumulation of disability.

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.

The treatment is administered in two courses over two years. Each course consists of two treatment cycles of about two weeks each, generally spaced about one month apart, at the beginning of each treatment year.

This totals a maximum of 20 days of oral treatment for the two-year period, which may be much less burdensome to patients than the regular self-injections, hospital infusions, or even daily tablet intake needed with other MS treatments.

“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,” said Wallace Brownlee, PhD, a consultant neurologist for the Cleveland Clinic London and the clinical lead for the multiple sclerosis service at the National Hospital for Neurology and Neurosurgery, also in London.

“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,” Brownlee added.