Endo International PLC filed an application with the U.S. Food and Drug Administration for the approval of Xiaflex injection to treat cellulite in the buttocks, a skin condition for which there is no approved drug-based treatment.
The share price of Dublin-based pharmaceutical company was up 30.1% as of 12:17 p.m. ET on Sept. 6.
The company's biologics license application is backed by results of two phase 3 trials, Release-1 and Release-2, that showed the injection improved the appearance of cellulite in the buttocks compared to placebo. Cellulite is caused by fat deposits pushing through the connective tissue beneath the skin, making the skin look dimpled and lumpy.
Xiaflex, or collagenase clostridium histolyticum, was originally approved by the FDA in 2010 for the treatment Dupuytren's contracture, which causes the connective tissue in the hand to thicken and tighten.
The U.S. regulator has 60 days to review the filing and decide if the application is complete and acceptable.
