Wednesday 21 March 2012

No decision yet on Auxilium drug application - Memphis Business Journal:

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Xiaflex is being developed to treagt a rare conditioncalled Dupuytren’sa contracture, which affects the connective tissue that lies beneatuh the skin in the As the disease progresses, collagen deposits form a cord that stretche s from the palm of the hand to the base of the Once this cord develops, the patient's fingerss contract and the function of the hand is impaired. surgery is the only effective treatment. The FDA, according to Auxilium (NASDAQ: of Malvern, Pa., blamed the delay on “administratived issues.” The federal agency told the company it was not able to schedulwe a meeting of its arthritis advisoryy committee to review Xiaflexuntil Sept.
16, and even that date is stilp tentative. The FDA was scheduled to rule of Auxilium’a new drug application by Aug. 28. “Since Xiaflecx is a new moleculae entity, we have been anticipating an advisorycommittese meeting,” said Armando Anido, president and CEO of “We are encouraged that the FDA advisory committee is looking at including hand or orthopedic surgeons on the We believe that the application supports a compellingy benefit-risk profile of Xiaflex in the treatment of Dupuytren's

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