March 23 Quick Takes: Venclexta combo hits in AML; plus Jardiance rebuffed, Zolgensma approved in Japan and Zealand-Boehringer
Partners Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) said Venclexta venetoclax plus azacitidine significantly improved overall survival and composite complete remission rate among acute myelogenous leukemia (AML) patients in the Phase III VIALE-A trial, compared with placebo plus azacitidine. Venclexta has accelerated approval from FDA in combination with azacitidine, decitabine or low-dose cytarabine to treat AML; a Venclexta/cytarabine combination failed to significantly improve OS in the Phase III VIALE-C trial, AbbVie announced Feb. 28. Venclexta is a small molecule inhibitor of BCL-2 (see “Growing Options”).
FDA has issued a complete response letter for an sNDA for Jardiance empagliflozin from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) to treat Type I diabetes as an adjunct to insulin. In November, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that available data do not support approval of the SGLT2 inhibitor. The drug is approved in Type II diabetes...