Endo International PLC (NASDAQ: ENDP) shares jumped on Friday after the company announced that it has submitted a Biologics License Application (BLA) to the U.S. 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 Release studies that were presented at the 2019 Annual Meeting of the American Academy of Dermatology and subsequently at the Aesthetic Meeting 2019.
A greater percentage of the 843 women treated during the studies met the primary endpoint of response with CCH versus placebo in both the Release-1 and Release-2 studies.
Additionally, statistically significant improvements with CCH versus placebo were observed for eight of eight (Release-1) and seven of eight (Release-2) secondary endpoints. All patient-centric endpoints, evaluated using validated patient-reported scales like Patient Reported Photonumeric Cellulite Severity Scale, Subject Global Aesthetic Improvement Scale, Patient Reported Cellulite Impact Score and Subject Self Rating Scale, 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 to moderate and injection-site related.
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.
Shares of Endo traded up about 19% on Friday to $2.82, in a 52-week range of $1.97 to $18.50. The consensus price target is $5.47.