Biotech Values

[DewDiligence]

SNY/REGN—FDA panel backs Praluent with reservations in 13-3 vote:

http://www.wsj.com/articles/fda-panel-backs-cholesterol-drug-but-raises-concerns-1433884972

A Food and Drug Administration advisory panel recommended that the agency approve the cholesterol-lowering drug Praluent, the first of a wave of such cardiovascular drugs [PCSK9] expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease.

But many panelists said the use of the drug should be limited to certain high-risk groups, such as people with very high cholesterol for genetic reasons because of a condition called familial hypercholesterolemia.

The committee voted 13-3 in favor of Praluent, from France’s Sanofi and Regeneron Pharmaceuticals Inc. But enough panelists expressed caution about the evidence in the companies’ studies, and so it may take longer than the industry would like to get these medicines widely used.