Praluent partners Sanofi and Regeneron have been battling for market share against Amgen’s Repatha in the PCSK9 class of cholesterol drugs, including by recently lowering their price. Now, the partners have won a label expansion that could neutralize a prior Repatha advantage.
On Friday, the FDA expanded Praluent’s label to include the drug's ability to reduce adult CV patients' risk of heart attack, stroke, and unstable angina requiring hospitalization. The approval is based on data generated from the partners’ Odyssey Outcomes trial, which they unveiled last year, and it matches a CV label expansion Repatha won back in December 2017.
In the Odyssey trial, patients on statins plus Praluent were 15% less likely to have a major CV event than those on statins and placebo. The Praluent patients were 27% less likely to have a stroke, 14% less likely to experience a nonfatal heart attack and 39% less likely to experience unstable angina requiring hospitalization. The drug also lowered the risk of death from any cause by 15%.
Praluent’s label update comes shortly after Sanofi and Regeneron significantly cut their list price for the drug, matching a similar move from Amgen in October. Now, Praluent and Repatha each cost $5,850 per patient per year before discounts, much lower than their launch tags of around $14,000. After the PCSK9 rollouts back in 2015, payers put up barriers to use and sales didn’t take off like analysts and market watchers expected.
“With this approval, and the recent introduction of a lower U.S. Praluent list price, we hope that more patients in need will be able to access Praluent,” Regeneron chief scientific officer George Yancopoulos said in a statement.
Praluent generated just €261 million in sales in 2018, its third full year on the market. In the first quarter of 2019, the drug posted €56 million and missed analyst expectations by 21%, according to a note from Jefferies analysts. For its part, Amgen's Repatha turned in $550 million in sales last year. That drugmaker reports first-quarter results on Tuesday.