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FDA Gives Esperion 'Clear Regulatory Path' to Approval of Cholesterol Drug

Monday, August 17, 2015   (0 Comments)
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From Bloomberg News
By Caroline Chen

Ann Arbor-based Esperion Therapeutics Inc. said U.S. regulators won’t require a trial to determine the effects of its experimental cholesterol drug on heart health, smoothing the path toward approval.
Shares of the biotech company gained 11 percent in extended trading in New York. They had risen 14 percent to close at $75.51 before the news was announced.

Esperion is developing ETC-1002 as a cholesterol-lowering therapy for patients who can’t be helped just by statins such as Pfizer Inc.’s Lipitor. Esperion will start a final-stage trial of the drug by the end of the year, the company said in a statement Monday.

“We now have a clear regulatory path forward,” CEO Tim Mayleben said on a conference call with analysts. Esperion will begin speaking to “a number of potential partners” to market the drug in and outside the U.S., he said.

While the U.S. Food and Drug Administration isn’t requiring a cardiovascular-outcomes study to be completed before approval, Esperion said it plans to run a trial anyway. It would measure the drug’s ability to reduce the risk of cardiovascular events such as a stroke and heart attack and, if successful, could help Esperion expand the drug’s approved uses to reach more patients.

The drugmaker estimated that 9 million patients in the U.S. could be eligible for its therapy in the initial label it is seeking.

ETC-1002 may compete with drugs called PCSK9 inhibitors by Amgen Inc., Sanofi and Regeneron Pharmaceuticals Inc. that work through a different mechanism and are taken as injections. Mayleben has said Esperion plans to set a price for its drug, which is taken orally, between generic statins and the PCSK9 inhibitors.

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