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 (proposed tradename Mavenclad) for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity.
”Today’s positive CHMP recommendation is an acknowledgement of the potential benefits that patients may achieve from treatment with Cladribine tablets. If approved, Cladribine tablets would be the first and only MS treatment to deliver and sustain four years of disease control from only 20 days of oral treatment over two years”, says Belinda Byrne, medical director, Merck UK & Ireland.
The CHMP positive opinion is based on more than 10,000 patient years of data with over 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 Phase II ONWARD study and long-term follow-up data from the eight-year prospective registry, PREMIERE. The efficacy 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 progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION study, no further Cladribine treatment was required in Years 3 and 4. The dataset has informed the posology and monitoring requirements. This dataset also provided safety information on the potential consequences of lymphopenia, infections, malignancies, and pregnancy. To help reduce these risks, Merck will be disseminating Educational Risk Minimisation Materials, a mandatory condition of the EU Marketing Authorisation which will be reviewed by the European Medicines Agency (EMA), MHRA, and HPRA.
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.