Merck’s treatment for relapsing MS receives positive CHMP opinion

Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Cladribine tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity.

This positive opinion has been based on clinical trial data from three Phase III trials, CLARITY, CLARITY EXTENSION and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the eight-year prospective registry, PREMIERE. These clinical trials included more than 10,000 patient years of data from over 2,700 patients allowing a full characterisation of the benefit-to-risk ratio to be made.

“The positive opinion from the CHMP is an extraordinary development for Merck, affirming our belief in Cladribine Tablets as a potential important treatment option for patients living with multiple sclerosis,” said Belén Garijo, member of the executive board of Merck and CEO Healthcare. “We now eagerly await the European Commission decision, and the opportunity to make a difference in the MS treatment paradigm.”

“We strongly believe in the therapeutic value of Cladribine Tablets and the significant impact this investigational therapy may have on the future of MS care,” said Luciano Rossetti, global head of R&D for the biopharma business of Merck. “There are still significant unmet needs for patients with MS, particularly those with high disease activity.”

It is anticipated that the European Commission will make a final decision on the marketing authorisation application for Cladribine Tablets within 67 days of the CHMP’s positive opinion.