EC approves first oral short-course treatment for highly active relapsing multiple sclerosis

Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years.

“Multiple Sclerosis (MS) is one of the world’s most common neurological disorders. With the approval of Mavenclad in the European Union, 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,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck. ”This is a pivotal change in the treatment of MS which further demonstrates our unwavering commitment to advancing patient care.” Mavenclad’s 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 for a full characterization of the benefit-to-risk profile of Mavenclad. “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 4 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 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 US. “Multiple Sclerosis affects more than 700,000 people across Europe and has no cure to date,” said Anne Winslow, President of the European Multiple Sclerosis Platform. ”New treatment options will significantly help improve the quality of life of people living with active relapsing MS.”