EU approves Mavenclad (Cladribine) for relapsing multiple sclerosis.-Merck KGaA.

Merck KGaA announced that the European Commission (EC) has granted marketing authorization for Mavenclad (Cladribine 10mg Tablets) for the treatment of highly active relapsing multiple sclerosis in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. The marketing authorization is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 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 8-year prospective registry, PREMIERE. The efficacy and safety results of these studies allowed a full characterization of the benefit-to-risk profile of Mavenclad.

The authorization follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in June 2017. Mavenclad is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as September 2017. In addition, Merck plans additional filings for regulatory approval in other countries, including the United States.