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Positive CHMP recommendation for Sanofi's atherosclerotic CVD drug Praluent

Published on 04/02/19 at 12:05pm

It has been announced that Sanofi’s Praluent (alirocumab) has been awarded a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) as a treatment to reduce cardiovascular risk in people with established atherosclerotic cardiovascular disease (ASCVD).

ASCVD refers to a number of conditions characterised by a build-up of plaque in the body’s arteries, with the resulting reduced blood flow increasing the risk of stroke, peripheral artery disease and acute coronary syndrome (ACS), which includes heart attack and unstable angina.

The CHMP’s decision recommended that the therapy be used as an adjunct to a maximally tolerated statin dose, or as a monotherapy in patients for whom statins are an inappropriate or ineffective approach. Phase 3 data on the therapy’s efficacy in 18,924 participants was submitted in support of its application.

The ruling bodes well for Sanofi, with the FDA historically tending to frequently follow the advice of the advisory panel. The French manufacturer expects a final decision from the European Commission in the coming months. The FDA has also accepted the drug for review, with a prospective decision date set for 28 April this year.

Matt Fellows

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