ROCKLAND, Mass. The Food and Drug Administration has declined to file a regulatory approval application from the U.S. subsidiary of Merck KGaA for a multiple sclerosis drug.
EMD Serono announced that the FDA had responded to its application seeking approval for cladribine tablets with a refuse-to-file letter, which indicates that the application is incomplete. EMD Serono said it would request a meeting with the FDA concerning the application.
“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,” Merck KGaA head of pharmaceuticals and board member Elmar Schnee said in a statement. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”
Merck KGaA is a separate company from the U.S.-based Merck & Co.