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

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Xiaflex is being developed to treat a rare condition called Dupuytren’s contracture, which affects the connective tissue that lies beneathh the skin in the palm. As the diseasde progresses, collagen deposits form a cord that stretchese from the palm of the hand to the base of the Once thiscord develops, the patient'z fingers contract and the function of the hand is Currently, surgery is the only effectivwe treatment. The FDA, according to Auxiliuk (NASDAQ: AUXL) of Malvern, Pa., blamed the delay on “administrative issues.” The federal agency told the compang it was not able to schedule a meetinhg of its arthritis advisory committe to review Xiaflexuntil Sept.
16, and even that date is stilp tentative. The FDA was scheduled to rule of Auxilium’ new drug application by Aug. 28. “Sincew Xiaflex is a new molecular entity, we have been anticipatingv an advisorycommittee meeting,” said Armando president and CEO of Auxilium. “We are encouraged that the FDA advisorg committee is looking at including hand or orthopedifc surgeons onthe panel. We believd that the application supports a compelling benefit-risk profile of Xiaflex in the treatmentg of Dupuytren's contracture.
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