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3 Mar 2011

FDA Rejects Merck's Multiple Sclerosis Drug

The first drug manufactured for multiple-sclerosis has been rejected by FDA.

In a complete response letter, the US FDA has rejected Merck's cladribine, the first drug manufactured to treat multiple-sclerosis.


The FDA recommended the German company to provide an improved understanding of safety risks and the overall benefit-risk profile, either through additional analyses or additional studies. Merck has said that it intends to request an end-of-review meeting with the FDA to clarify next steps and to identify whether data from completed and ongoing clinical studies can address the agency's questions.


Cladribine is a small molecule that may interfere with the behaviour and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pa

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