FDA advisory panel votes in favor of approving Praluent

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration yesterday voted to recommend the approval of the investigational therapy Praluent (alirocumab) Injection from US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN).

The Committee voted 13 to three (with no abstentions) that Regeneron and Sanofi had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations. However, some members of the advisory panel suggested that the use of the PCSK9 inhibitor should be limited to certain patients, such as those with familial hypercholesterolemia. Several members of the panel said that while statin drugs have been shown to lower cholesterol and reduce cardiac disease, it is not clear if these new PCSK9 drugs will do the same.

Trading in Regeneron’s shares was suspended while the advisory committee deliberated, but the dipped 2.7% to $526.09 in after-hours business o Tuesday. Sanofi was little changed in trading this morning,