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Print Edition StoriesMonday, November 30, 2009
EMD Serono NDA for MS drug gets FDA refuse-to-file response
By Mass High Tech staff
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The U.S. Food and Drug Administration has refused to file a New Drug Application it received from Rockland biopharmaceutical firm EMD Serono Inc. for the company’s Cladribine tablets, an oral drug treatment for relapsing multiple sclerosis.
According to a release from the company, a refuse-to-file letter from the FDA usually indicates an NDA has not been completed sufficiently. EMD Serono officials said they plan to schedule a meeting with the FDA to discuss the necessary steps to complete the NDA sufficiently.
If approved, Cladribine would become the first orally administered drug for relapsing MS available; current relapsing MS treatments are administered parenterally.
The company’s Phase 3 trial of Cladribine concluded after two years with success in meeting its primary and secondary endpoints.
To date, the FDA has given Cladribine fast track status to send it quickly through the pipeline to treat patients for recurring multiple sclerosis.
EMD Serono is a subsidiary of Merck KGaA of Darmstadt, Germany. The company focuses its treatments on neurodegenerative diseases and diseases associated with endorcrinology and reproduction.
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