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FDA rejects Savient's Krystexxa application

The FDA has rejected Savient Pharmaceuticals' application for a Biologics License for Krystexxa (pegloticase) as a treatment for chronic gout

The FDA has rejected Savient Pharmaceuticals' application for a Biologics License for Krystexxa (pegloticase) as a treatment for chronic gout in patients who do not respond to conventional therapy.

In a complete response letter, the FDA cites deficiencies with the chemistry, manufacturing and controls section of the Biologics License Application. Savient is to request a meeting to clarify the issues raised and says that the company believes that a re-submission would respond to all the deficiencies cited in the FDA's letter.

Paul Hamelin, president of Savient Pharmaceuticals, said: "While our timeline for re-submission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our re-submission for early 2010." He added: "While we believe we have made substantial progress toward the potential final approval of Krystexxa, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for Krystexxa so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."

Savient describes pegloticase as its 'flagship product-in-development' and the treatment (which is delivered by intravenous infusion) achieved significant positive results in its phase III programme on treatment-failure gout patients. This was conducted under the auspices of a Special Protocol Assessment with the FDA and was granted orphan drug designation.

At the end of 2008, the FDA accepted for review Savient's Biologics License Application for Krystexxa and granted it with a priority review status, which accelerates the review period to six months. A priority review designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available.

One of the issues now raised by the FDA in the complete response letter indicates that the data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of Krystexxa in its phase III clinical trials.

3rd August 2009

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