February 24, 2014
Auxilium Pharmaceuticals, Inc. a fully integrated specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission of a supplemental Biologics License Application (sBLA) requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren’s contracture (DC) cords concurrently. The PDUFA (Prescription Drug User Fee Act) date for the sBLA filing is October 20, 2014.
Dupuytren’s contracture is a progressive hand disease that can present with multiple collagen “cords” that limit finger movement and hand function. It is estimated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time. The sBLA, seeking expansion of the labeling for the concurrent treatment of two palpable cords, is based on positive results from the global, multicenter Phase 3b MULTICORD (Multiple Treatment Investigation of CollagenaseOptimizing the Resolution of Dupuytren’s) trial, together with data from the Company’s earlier studies (AUX-CC-861 and AUX-CC-864). The study also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection.
XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S., for the treatment of adult men with Peyronie’s disease (PD) with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.
About Dupuytren’s Contracture
Dupuytren’s disease is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with Dupuytren’s there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren’s cord can reduce the finger’s range of motion (how much a person can move or straighten them). Once the Dupuytren’s collagen cord can be felt, it is referred to as a “palpable cord.”
XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren’s contracture patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD. Additionally, CCH is currently being studied in clinical trials in the following collagen-related conditions: frozen shoulder syndrome (Phase 2), cellulite (Phase 2), and lipoma (Phase 2).
Find the full press release here.