FDA Refuse New Drug Application For Merck Cladribine Tablets

Merck KGaA announced that its US affiliate received a refuse to file letter from the FDA on the New Drug Application (NDA) for Cladribine tablets, Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

Elmar Schnee, executive board member of Merck and head of the Merck Serono division, said: “The company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time.

“We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”

Merck Serono plans to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission and to reach an understanding on what would be required for the Cladribine tablets NDA to be accepted for review.