Friday, 24 September 2010

Oral Cladribine turned down by the European Medicines Agency

Despite evidence that oral cladribine is effective in relapsing-remitting MS the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorization for Cladribine Tablets. The CHMP have concerns about the long-term safety of Cladribine.

In my opinion, long-term safety data can only be obtained from post-marketing surveillance studies and the extension study of the pivotal clinical trial. Unfortunately, there are probably not enough patients in the latter study to answer this question. It is a good thing that the drug is licensed in Russia and Australia.

Click here for press release from Merck-Serono

Click here for Bloomberg's press release

Click here for the abstract of the CLARITY study

1 comment:

  1. Yes, it would be a good idea to see just how many MS patients can get cancer from a widespread roll out of this drug. Whatever happened to "I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone"?

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