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Praluent's partners, Sanofi and Regeneron, are competing for market share against Repgen de Amgen in the PCSK9 cholesterol class, notably by lowering their price recently. Now, the partners have obtained an extension of the label that could neutralize a previous advantage of Repatha.
On Friday, the FDA expanded the Praluent label to include the ability of this drug to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adult CV patients. The approval is based on data generated from the Odyssey Outcomes partner trial, which they unveiled last year, and is an extension of the CV label that Repatha obtained in December 2017.
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In the Odyssey trial, patients on statins plus Praluent were 15% less likely to have a major cardiovascular event than those on statins and placebo. Praluent patients were 27% less likely to have a stroke, 14% less likely to have a nonfatal heart attack, and 39% less likely to have unstable angina requiring hospitalization. The drug has also reduced the risk of death by 15%, whatever the cause.
The update of Praluent's labels comes shortly after Sanofi and Regeneron significantly reduced their catalog price for the drug, which is a similar change made by Amgen in October. Now, Praluent and Repatha each cost $ 5,850 per patient per year before discounts, much less than their launch labels of about $ 14,000. After the PCSK9 roll-out in 2015, payers lifted barriers to use and sales did not take off as expected by analysts and market watchers.
Profit has generated only a turnover of 261 million euros in 2018, its third full year on the market. In the first quarter of 2019, the drug registered 56 million euros and missed analysts' expectations by 21%, according to a note from Jefferies analysts. Repatha d'Amgen had a turnover of $ 550 million last year. This drug maker publishes its first quarter results on Tuesday.
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