Regulatory Affairs

European Commission grants approval for Mavenclad

Published 28 August 2017

Merck announced that the European Commission (EC) has granted marketing authorization for Mavenclad 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis*(RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.

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.

"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,[2] and up to 10 years of observation in some patients.

The clinical development program included data from three Phase III trials, CLARITY[3],[4], CLARITY EXTENSION[5] and ORACLE MS[6]; the Phase II ONWARD study[7]; and long-term follow-up data from the 8-year prospective registry, PREMIERE.[8] The efficacy and safety results of these studies allowed 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 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 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.

"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."

In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial[3],[4] demonstrated that MAVENCLAD® reduced the annualised relapse rate by 67% and the risk of 6-month confirmed EDSS progression by 82% versus placebo.

 As demonstrated in the Phase III CLARITY EXTENSION[5] study, no further MAVENCLAD® treatment was required in Years 3 and 4. The comprehensive dataset has informed the posology and monitoring requirements.

The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Lymphocyte counts must be assessed before, and during, treatment with MAVENCLAD®. MAVENCLAD® is contraindicated in certain groups including immunocompromised patients and pregnant women.

MAVENCLAD® (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis* (RMS).

MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS).

MAVENCLAD® is currently under clinical investigation and not yet approved for the treatment for any use in the United States or Canada. In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.

MAVENCLAD® (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.

Source: Company Press Release