BRIEF—Endo files BLA for collagenase clostridium histolyticum in patients with cellulite

Ireland-incorporated Endo International has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

The submission is based on positive results from two identical Phase III RELEASE studies that were presented at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington DC and subsequently at the The Aesthetic Meeting 2019 in New Orleans, LA.

The RELEASE-1 and RELEASE-2 Phase III studies, which were identically designed, randomized, double blinded and placebo-controlled, assessed the efficacy and safety of CCH for the treatment of cellulite in women.

A greater percentage of the 843 women treated during the studies (CCH versus placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of response with CCH versus placebo in both the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies.

The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. Endo will communicate the FDA's decision.