The European Commission has approved Mavenclad, more commonly known as cladribine, for the treatment of highly active relapsing remitting multiple sclerosis (RRMS) patients across Europe. The authorisation has been given across 28 countries within the European Union (EU), in addition to Norway, Liechtenstein and Iceland. The first launches will be in the UK and Germany.
Cladribine is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active RRMS, including disability progression, annualised relapse rate and magnetic resonance imaging (MRI) activity.
Commenting on the approval, Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck, said: “We are pleased to offer patients and clinicians an innovative agent with a simplified dosing schedule as a new approach to managing active relapsing MS”
“This is an exciting moment and one that will change the way we treat MS,” said Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “Mavenclad is a selective immune reconstitution therapy (SIRT) which simplifies treatment administration, by giving patients just two short annual courses of tablets in four years. Patients can benefit from the treatment over a longer period of time without having to continually take medication and without the need for frequent monitoring.”
The authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in June 2017. According to Merk’s website, Cladribine 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, drug maker, Merck plans to file for additional regulatory approval in other countries, including the United States.