Merck receives EU approval for new multiple sclerosis drug Mavenclad

Merck has received European regulatory approval for a new treatment for highly active relapsing multiple sclerosis.

The European Commission has granted marketing authorisation for Mavenclad, the first oral short-course treatment for highly active relapsing multiple sclerosis to be approved in Europe, based on its strong performance in clinical trials.

It has demonstrated efficacy across a number of key measures of disease activity in patients with this form of multiple sclerosis, including disability progression, annualised relapse rate and magnetic resonance imaging activity.

More than 10,000 patient years of data was submitted to support this authorisation, with over 2,700 patients included in the clinical trial programme and up to ten years of observation generated for certain patients. 

Belen Garijo, chief executive officer for healthcare and member of Merck's executive board, said: "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 multiple sclerosis."

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