NICE rebuffs Praluent, reverses course on Repatha
The U.K.'s NICE issued draft guidance recommending against the use of Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) alone or in combination with lipid-lowering therapies to treat primary hypercholesterolemia or mixed dyslipidemia.
NICE expressed concern that Praluent had not been compared with the combination of a statin and Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK) in patients with non-familial hypercholesterolemia. The committee also said that although it was "reasonable to infer that alirocumab would reduce cardiovascular events, the extent of this reduction was uncertain." Sanofi expects results in 2017 from a cardiovascular outcomes trial (CVOT) of Praluent. ...