Science and technology company, Merck has revealed it has received a positive opinion from the European Medicines Agency (EMA), part of the Committee for Medicinal Products for Human Use (CHMP), for approval of cladribine tablets, also known as Mavenclad. The tablets will be for the treatment of relapsing remitting multiple sclerosis (RRMS) in patients with high disease activity.
The positive opinion is based on more than 10,000 patient years of data with more than 2,700 patients included in the clinical trial program and more than 10 years of observation in some patients.
The clinical development program included data from three phase III trials, Clarity, Clarity Extension and Oracle MS. The efficiency and safety results of these studies allowed a full characterisation of the benefit-to-risk profile of cladribine tablets.
In patients with high disease activity, post hoc analyses of the two-year Phase III Clarity trial demonstrated that cladribine tablets reduced the annualised relapse rate by 67% and the risk of six-month confirmed EDSS (Expanded Disability Status Scale) progression by 82% versus placebo. As demonstrated in the Phase III Clarity Extension study no further cladribine treatment was required in years three and four. The comprehensive dataset has informed the posology and monitoring requirements. The most important side effects are lymphopenia, which can be severe and long-lasting, and infections, including herpes zoster.
The CHMP’s recommendation will be referred to the European Commission which is expected to make a final decision on the marketing authorisation application for cladribine tablets within 67 days from the CHMP opinion.
“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 MS,” 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.”
Source: MS-UK (26/06/17)