EU Approves Merck KGaA MS Tablets for Marketing
The European Commission has granted marketing authorization for Merck KGaA’s Cladribine tablets for treatment of highly active relapsing multiple sclerosis (RMS) in the EU 28, in addition to Norway, Liechtenstein and Iceland.
Initial launches are expected to start as early as September 2017 in Germany and the UK, with additional filings for regulatory approval planned for countries outside the EU, including the US.
Mercks said Mavenclad is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active RMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity. The tablets have shown sustained clinical efficacy for up to four years with a maximum of 20 days of oral treatment over two years, it added.
The Commission’s marketing approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) received in June 2017. The German chemicals and pharmaceuticals producer said the authorization is based on more than 10,000 patient years of data with over 2,700 patients in clinical trials and up to 10 years of observation in some patients.
Multiple sclerosis, which has no cure to date, affects more than 700,000 people across Europe.
