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EMD Serono MS drug delayed

The US Food and Drug Administration extended the review period of an EMD Serono multiple sclerosis drug by three months

The US Food and Drug Administration (FDA) has pushed back the date by which it will make its decision on a marketing application for a new multiple sclerosis (MS) drug filed by EMD Serono, an affiliate of Germany's Merck KGaA. The FDA said it has extended the review period by three months and now expects to make a decision by February 28, 2011.

EMD Serono is aiming to market cladribine tablets in the US as a therapy for relapsing forms of MS. The product is a proprietary oral formulation of the drug.

The company had hoped that the drug would be the first orally administered disease-modifying therapy for relapsing MS, as only parenterally administered disease-modifying therapies were approved for the indication in the US at the time it submitted its application. However, in September, the FDA approved Novartis' oral pill Gilenya (fingolimod) for the indication.

The US marketing application for the EMD Serono drug was granted a priority review, meaning that the FDA initially intended to make a decision within six months, rather than the standard 10 months, and had set November 28 as the target date.

However, the FDA said it needed additional time to review new information that had been added to the drug application and so would not be able to meet the original target.  The US marketing application was filed in June.  It was the company's second attempt: in November 2009, the FDA refused to file the original application in the form in which it was submitted.

Following the new setback, the company said it remains committed to the drug and will continue to work closely with the FDA.

Cladribine tablets were approved in Russia in July and in Australia in September for relapsing-remitting MS.  However, also in September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the marketing application, maintaining that based on currently available data, the benefits of the therapy do not outweigh its risks.

The marketing application for the drug is supported by the results from the CLARITY study, which enrolled 1,300 patients, making it the largest placebo-controlled phase III clinical trial ever completed in relapsing-remitting MS.

29th November 2010

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