Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic
FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease. The GLP-1 agonist led to a 26% relative risk reduction of MACE vs. placebo in the Phase III SUSTAIN 6 CV outcomes trial. The drug already had FDA approval to improve glycemic control in adults with Type II diabetes.

PDUFA date for Intercept NASH candidate now June 26
Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) disclosed in a regulatory filing that FDA extended by three months the PDUFA date for Ocaliva obeticholic acid to treat non-alcoholic steatohepatitis, to June 26 from March 26. The company expected the change after FDA set a tentative date of April 22 for an advisory committee meeting to review the oral FXR agonist...