Merck KGaA pulls plug on cladribine on FDA feedback

(Reuters) – Merck KGaA said U.S. drug regulators’ concerns about the risks of its cladribine pill will put an end to any development or marketing plans for the multiple sclerosis (MS) treatment.

Merck also said on Wednesday it planned to withdraw cladribine from markets in Australia and Russia where it has been approved and is available under the name Movectro.

“Merck believes that data from ongoing clinical trials are very unlikely to address the (U.S. Food and Drug Administration’s) requirements,” it said, adding new trials would not justify the costs.

• Caroline says: Merck/Serono will not pursue an MS approval for oral cladribine. The drug was rejected by the FDA in March 2011 because of safety concerns. Oral cladribine is currently approved in Russia and Australia, and will be withdrawn from the markets there as well, according to this article.
   

• Related Links:
• http://uk.reuters.com/article/2011/06/22/health-us-merckkgaa-cladribine-idUKTRE7…

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