BioSpecifics Tech. Reports FDA Approval Of SBLA For XIAFLEX - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has approved the supplemental Biologics License Application or sBLA submitted by BioSpecifics Technologies Corp.'s (BSTC) partner, Auxilium Pharmaceuticals Inc., for XIAFLEX for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit. In 2010, XIAFLEX obtained FDA approval as the first and only nonsurgical treatment for adult Dupuytren's contracture patients with a palpable cord in the palm.

The expanded label also allows the ability to delay the finger manipulation procedure from 24 to up to 72 hours.

"We are very excited by this label expansion for XIAFLEX as it allows physicians to treat more than one Dupuytren's cord at the same time, bringing added convenience to the physician and offering broadened treatment options to patients who would prefer to avoid an invasive surgical procedure. Market share of XIAFLEX for Dupuytren's contracture has been steadily increasing, across all procedures, and we believe this label expansion will lead to even more growth since it is estimated that 35 to 40 percent of Dupuytren's surgeries treat more than one cord," commented Thomas Wegman, President of BioSpecifics.

He added, "In addition to growth from the expanded label, we also look forward to broadening the commercial reach of XIAFLEX into markets outside the U.S. with the potential approval in Japan for Dupuytren's contracture and in the EU for Peyronie's disease. With all of these avenues to reach new patients with XIAFLEX, we expect to see continued commercial success through 2015."

The sBLA was based on positive results from the global, multicenter Phase 3b MULTICORD trial, along with data from Auxilium's earlier studies.