Merck Unit Gets FDA Approval for Multiple Sclerosis Drug Mavenclad

Merck KGaA’s (MRK.KE, MKKGY) EMD Serono Inc. business has received Food and Drug Administration approval for the multiple sclerosis drug Mavenclad, or cladribine.

The FDA said it approved the tablets for treating relapsing forms of multiple sclerosis in adults, including relapsing-remitting disease and active secondary progressive disease.

Mavenclad isn’t recommended for patients with clinically isolated syndrome, the agency said. Because of its safety profile, use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate multiple sclerosis drugs, the FDA said.

The drug significantly decreased the number of relapses in a clinical trial in 1,326 patients, according to FDA.

Mavenclad, the subject of an FDA complete response letter in 2011, was resubmitted in 2018.

Before the FDA approval, it had been cleared in 52 countries. Merck KGaA announced on Monday that it was approved in Switzerland.

https://www.marketscreener.com/MERCK-KGAA-436395/news/Merck-Unit-Gets-FDA-Approval-for-Multiple-Sclerosis-Drug-Mavenclad-28264167/