Sanofi, Regeneron's PCSK9 inhibitor Praluent approved in EU

The European Commission approved Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab) for the treatment of LDL cholesterol in certain adults with hypercholesterolaemia, the companies announced Monday. Sanofi and Regeneron noted that the product is the only PCSK9 inhibitor cleared in Europe that is available in two starting doses as a single injection given once every two weeks.

Specifically, Praluent is authorised for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, either in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or alone, or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The drugmakers indicated that Praluent will be available in a single-dose pre-filled pen that patients self-administer.

The approval was based on data from 10 Phase III ODYSSEY trials, with Sanofi and Regeneron noting that results "showed consistent, robust reductions" in LDL-C for Praluent compared to placebo or Merck & Co.'s Zetia (ezetimibe), when added to current standard-of-care, which included maximally-tolerated statins. The companies said that all of the trials met their primary efficacy endpoints, demonstrating significantly greater reductions from baseline in LDL-C at week 24 ranging from 45 percent to 61 percent.

In July, Praluent was approved for use in the US as an adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Sanofi and Regeneron indicated that the ability of Praluent to reduce major cardiovascular events is being investigated in the ongoing ODYSSEY OUTCOMES trial, with results anticipated in 2017.

Last month, the FDA cleared Amgen's PCSK9 inhibitor Repatha (evolocumab), with the therapy having won European approval in the previous month. The cost of PCSK9 inhibitors, which have been set at over $14 000 per year in the US, have been questioned, with a recent analysis suggesting that the price that best represents the overall benefits the drugs may provide would be at a 67 percent discount to their list prices. In Europe, Amgen disclosed that Repatha will be priced at a discount to the US, with the product costing 340.20 pounds ($517.33) for a 28-day supply in the UK.

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