EMD Serono, an affiliate of Merck KgaA, Darmstadt, Germany, announced that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).
“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,” said Elmar Schnee, member of the executive Board Merck KGaA and Head of Pharmaceuticals. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”
Based on current regulations, once a NDA is submitted to the US FDA, the Agency has 60 days to preliminarily review the NDA submission and assess whether the NDA is sufficiently complete to permit a substantive review. If it determines that the NDA is not sufficiently complete, the US FDA issues a refuse to file letter to the applicant. EMD Serono plans to request a meeting with the US 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.
EMD Serono’s oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS).
EMD Serono an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives.