Posted by Michael Wonder on 07 Sep 2019
Endo announces submission of biologics license application to FDA for collagenase clostridium histolyticum in patients with cellulite
6 September 2019 - Endo International announced today that the Company has submitted a biologics license application to the U.S. FDA for collagenase clostridium histolyticum for the treatment of cellulite in the buttocks.
The submission is based on positive results from two identical Phase 3 RELEASE studies that were were presented at the 2019 Annual Meeting of the American Academy of Dermatology in Washington, DC and subsequently at the The Aesthetic Meeting 2019 in New Orleans, LA.
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were identically designed, randomised, double blinded and placebo-controlled, assessed the efficacy and safety of CCH for the treatment of cellulite in women.
