​​Sanofi, Regeneron to continue Praluent cardiovascular outcomes trial

Sanofi and Regeneron Pharmaceuticals on Thursday announced that a cardiovascular outcomes trial of the PCSK9 inhibitor Praluent (alirocumab) will continue as planned. The companies noted that the decision was made on the basis of the recommendation of an independent Data Monitoring Committee after the completion of a second pre-planned analysis.

The ODYSSEY OUTCOMES study involves more than 18 000 patients and is designed to demonstrate that Praluent reduces the risk of serious cardiovascular events, such as myocardial infarction and stroke. In the trial, enrolment in which was completed last year, patients receiving maximally tolerated statins were randomised to treatment with Praluent or placebo once every two weeks. The Praluent dose was doubled after eight weeks for all patients whose LDL cholesterol levels remained above 50 mcg/dL. 

Commenting on the news, ISI Evercore analyst John Scotti noted that the criteria for halting the study early were a 20-percent decrease in the risk of myocardial infarctions or strokes and a positive trend towards diminished risk of heart disease-related death. Scotti said it is "impossible to tell at this stage how it will play out," given the possible reasons the trial was continued. The analyst added "it's clear that the effect size [at this stage of the trial] was not large enough to stop the trial early, but [we] would caveat from reading in too much to the end result."

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Praluent was approved in the US and EU last year for the treatment of hypercholesterolaemia in certain adults, while the product is now authorised in around 40 countries. Meanwhile, Amgen's PCSK9 inhibitor Repatha was also cleared for use in Europe and the US last year. Amgen has similarly launched a large study seeking to assess the effects of Repatha in combination with statins on cardiovascular outcomes, with Scotti suggesting that data may be available as early as January next year.

A study published in August suggested that the prices of Praluent and Repatha should be dramatically cut in the US to make them cost-effective. Similarly, a 2015 analysis by the Institute for Clinical and Economic Review called for a 67-percent decrease in the list prices of both drugs. Recently, Imperial College London professor Kausik Ray commented "even if the outcomes studies are positive [these drugs are] still going to cost $14 000 a year." Ray added "the prices should come down because at the current rate, people are not going to be able to afford them." 


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