Feb. 18 Quick Takes: Label expansion for Entresto; plus Amgen, Sesen, BeiGene, Cortexyme and more
Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved Entresto sacubitril/valsartan to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure. The approved population includes heart failure patients with reduced ejection fraction and those with preserved ejection fraction. In December, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 12 to 1 that clinical data support the use of Entresto in the expanded indication.
Priority review for Amgen’s KRAS inhibitor, Sesen’s bladder cancer therapy
Amgen Inc. (NASDAQ:AMGN) said FDA granted priority review to an NDA for sotorasib to treat patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) following at least one systemic therapy. The PDUFA date for the KRAS G12C inhibitor is Aug. 16. ...