The biologics license application (BLA) submission is based on data from a total of 1,082 treated Dupuytren’s contracture patients and over 2,600 injections of Xiaflex.
Auxilium has requested priority review designation for this BLA submission from the FDA. The company expects to hear back from the FDA on priority review designation within approximately 60 days from the filing date. If granted, the FDA, per Prescription Drug User Fee Act guidelines, has up to six months from submission date to take action on the BLA.
Armando Anido, CEO and president of Auxilium, said: “We believe that Xiaflex, if approved, would be the non-surgical treatment choice for the management of Dupuytren’s contracture and could meaningfully improve the lives of patients diagnosed with the disease. We look forward to working with the FDA as it reviews the Xiaflex application.”