FDA Advisory Committee Recommends Approval Of Xiaflex

BioSpecifics Technologies (BioSpecifics) has reported that the Arthritis Advisory Committee appointed by the FDA has unanimously recommended that Xiaflex (collagenase clostridium histolyticum), a new orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren’s disease.

Reportedly, Auxilium Pharmaceuticals has licensed the rights to Xiaflex from BioSpecifics for three clinical indications: Dupuytren’s disease; Peyronie’s disease; and frozen shoulder (adhesive capsulitis).

Thomas Wegman, president of BioSpecifics, said: “We believe that the Advisory Committee’s very supportive vote for Xiaflex represents a major advance for both the patients suffering from Dupuytren’s disease, as well as for BioSpecifics and its shareholders. We look forward to the FDA’s decision regarding the approval of Xiaflex.”