FDA Rejects Merck KGaA’s NDA for MS Treatment

Merck KGaA has received a refuse-to-file letter from the FDA for its cladribine NDA to treat relapsing forms of multiple sclerosis (MS). The German drugmaker plans to work closely with the FDA to resolve concerns and resubmit the application as soon as possible, Elmar Schnee, Merck executive board member and head of its Serono division, says in a statement. When the company submitted the NDA in October, it said the investigational cladribine tablets have the potential to become the first oral disease-modifying therapy for patients with relapsing forms of MS.
Drug Industry Daily