Biotech Values

[DewDiligence]

FDA approves NVS’ Entresto (f/k/a LCZ696) for heart failure:

http://finance.yahoo.com/news/novartis-heart-failure-medicine-lcz696-205000626.html

Novartis announced today that the US Food and Drug Administration has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB).

Entresto is an FDC that contains Diovan (an ARB that was formerly NVS’ biggest-selling drug) and Sacubitril, a new agent that works by inhibiting neprilysin.

The approval came one month before the PDUFA date. Some analysts (and NVS) expect Entresto to reach peak annual sales of $5B.