Biotech Values

[DewDiligence]

SNY/REGN—FDA approves Praluent (with more restrictive label than EMA):

http://t.co/qfYOFlysPb

The U.S. Food and Drug Administration today approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Note the difference between the above and the EMA’s broader label (#msg-115659856), which includes primary prevention and statin intolerance.