Merck KGaA resubmits Cladribine for FDA approval

German drugmaker Merck KGaA (MRK: DE), known as EMD in the USA and Canada, announced on Monday that its resubmission of Mavenclad (cladribine) has been accepted for review by the US Food and Drug Administration (FDA).

This submission comes after Merck's first attempt to gain US approval for Mavenclad in 2011, when it was rebuffed by the FDA due to a lack of safety data.

The FDA agreed to reevaluate Mavenclad's potential after Merck provided a substantially larger dossier of safety information, totalling more than 12,000 patient years of information including decade-long records on some individual patients.