Endo International plc announces it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.
The submission is based on positive results from two identical Phase 3 Randomized EvaLuation of CEllulite Reduction by CollAgenaSE Clostridium Histolyticum (RELEASE) studies that were 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, the company notes in a media release.
The RELEASE-1 and RELEASE-2 Phase 3 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 vs. 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.
In addition, statistically significant improvements with CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. All patient-centric endpoints, evaluated using validated patient-reported scales like Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS), Subject Global Aesthetic Improvement Scale (S-GAIS), Patient Reported Cellulite Impact Score (PR-CIS) and Subject Self Rating Scale (SSRS), showed statistically significant improvement in the CCH group when compared to the placebo group. Most adverse events observed in CCH-treated patients were transient, mild/moderate and injection-site related (e.g., bruising, pain, induration, pruritus, erythema, and discoloration), the release continues.
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, it shares in the release.
[Source(s): Endo International plc, BioSpace]