Praluent alirocumab regulatory update

EMA’s CHMP recommended approval of Praluent alirocumab from Sanofi to treat adults with primary hypercholesterolemia or mixed dyslipidemia. Specifically, the human mAb targeting PCSK9 is recommended as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin; or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated. Sanofi expects a final decision from the European Commission in late September. ...