Analyst sees positive future for Merck in MS market, as FDA accepts Mavenclad for review

The US Food and Drug Administration’s acceptance of Merck KGaA’s (MRK: DE) resubmitted application for Mavenclad (cladribine), seven years after the original application,  is seen as a positive in terms of the German drugmakers future in the multiple sclerosis therapy sector.

Offering his view, analytics company GlobalData pharma analyst Rahael Maladwala says: “Merck KGaA have placed themselves in a strong position in the multiple sclerosis market with the expected approval of Mavenclad in the US within the next 12 months. The drug has demonstrated good efficacy, compared to other rival treatments, and while there are still a relatively higher incidence of adverse events compared to other drugs on the market, major safety concerns with the drug have been eased by studies carried out over the last five years.

“Merck KGaA originally submitted Mavenclad (cladribine) tablets to the FDA for review in 2011, for the treatment of relapsing forms of multiple sclerosis. However they received a complete response letter (CRL) stating a need for new studies looking into the safety of the drug.