EMD Serono Receives Refuse to File Letter from FDA on Cladribine Tablets NewDrug Application

EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany, announced today that it received a refuse to fileletter from the US Food and Drug Administration (FDA) on the New DrugApplication (NDA) for Cladribine Tablets, EMD Serono’s proprietaryinvestigational oral formulation of cladribine, as a therapy for relapsingforms of multiple sclerosis (MS). “The company will work closely with the FDA to fully understand FDA’sconcerns and define a path forward for a successful resubmission of thisapplication at the earliest point in time,” said Elmar Schnee, Member of theExecutive Board Merck KGaA and Head of Pharmaceuticals. “We remain focused ondelivering on our promise to transform the way people living with multiplesclerosis approach their therapy options.” Based on current regulations, once a NDA is submitted to the FDA, theAgency has 60 days to preliminarily review the NDA submission and assesswhether the NDA is sufficiently complete to permit a substantive review. If itdetermines that the NDA is not sufficiently complete, the FDA issues a refuseto file letter to the applicant. EMD Serono plans to request a meeting withthe FDA as soon as possible to discuss its comments on the NDA submission andto reach an understanding on what would be required for the Cladribine TabletsNDA to be accepted for review.