FDA Extends Priority Review of Cladribine in Relapsing MS

FDA extended the review to 'provide additional time for a full review of additional information provided under the new drug application.'

A release from the company notes that the FDA extended the review to "provide additional time for a full review of additional information provided under the new drug application."

Cladribine was approved for relapsing MS earlier this year in Australia and Russia, but in September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion on cladribine. The CHMP opinion stated that, in the committee's view, the benefits of treatment did not outweigh the risks, a decision that did not bode well for FDA approval. The company announced in October that they plan to appeal the negative opinion.

Good News or Bad News?

The Wall Street Journal reported today that Merck KGaA shares were up on the strength of this news, which some analysts have taken as a positive sign after the negative opinion in the large European market. Others feel the delay on an answer is still not good.

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