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ARTICLE | Company News

Dec. 13 Company Quick Takes: Horizon, Intercept, Imfinzi, Evenity and Numab-3SBio

December 14, 2019 12:57 AM UTC

FDA panel backs Horizon's eye disease candidate
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously Friday that the benefits of teprotumumab to treat active thyroid eye disease outweigh the potential risks. The mAb against IGF1R from Horizon Therapeutics plc (NASDAQ:HZNP) is under Priority Review with a March 8 PDUFA date. If approved, the therapy would be the first for the indication.

Advisory meeting could push out PDUFA for Intercept’s NASH therapy
Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said it expects FDA to move back the March 26 PDUFA date for obeticholic acid after the agency set a tentative date of April 22 for an advisory committee meeting to review the candidate. Intercept also said it submitted an MAA to EMA for the oral FXR agonist to treat non-alcoholic steatohepatitis. The company markets obeticholic acid as Ocaliva for primary biliary cholangitis...