Endo Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: PR Newswire
DUBLIN, Sept. 6, 2019 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that the Company 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 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 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
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