Leading science and technology company, Merck, has now announced the European Commission’s approval of its cladribine 10-mg tablets (Mavenclad, Merck KGaA) for the treatment of highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.
Cladribine is an antimetabolite that depletes lymphocytes by causing DNA strand breaks and interfering with DNA synthesis. Cladribine has been shown to reduce the frequency of relapses and to delay disease progression.
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,” Merck said in a news release.
“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 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.
