By Dania Nadeem and Trisha Roy
(Reuters) – Esperion Therapeutics Inc said on Friday that U.S. health regulators approved its cholesterol-lowering drug, making it the first non-statin treatment to be cleared for sale in the country in nearly 20 years.
The drug, bempedoic acid, to be used as an add-on treatment with statins, lowers bad cholesterol or low-density lipoprotein (LDL) by inhibiting its synthesis in the liver and is aimed at patients with high cardiovascular risk, the company said in a statement.
The oral treatment, which will be sold under the brand name Nexletol, is expected to be priced at around $10 per pill and will be available in the United States through prescription from March 30, Esperion said.
The approval of bempedoic acid is an important de-risking milestone for the company and marks its transition from a clinical-stage story to a commercial-stage story, Jefferies analyst Michael Yee said.
The drug’s approval by the U.S. Food and Drug Administration comes after studies showed an 18% to 28% fall in LDL cholesterol, compared with placebo, in patients who were also on statin.
High LDL cholesterol is known to raise the risk of heart attacks or strokes as it leads to fat build-up on the walls of arteries. About 18 million Americans with heart disease live with elevated levels of LDL cholesterol, Esperion said.
Half of these patients are unable to keep their cholesterol in check despite being on statins, such as Pfizer Inc’s Lipitor, while the other half cannot tolerate statin due to side effects such as muscle pain, nausea, and liver dysfunction, according to the company.
“Having a non-statin, once-a-day pill to combine with statin is really what physicians see as needed today,” Esperion Chief Executive Officer Tim Mayleben told Reuters.
Mayleben also said the company was in active discussions with insurers to ensure that patients have access to the drug.
Injectable drugs such as Sanofi SA and Regeneron Pharmaceuticals Inc’s Praluent and Amgen Inc’s Repatha are not popular with insurers, given that they are priced at about $6,000 a year.
Stifel analyst Derek Archila expects the drug to bring in sales of about $3 billion by 2029 at its peak.
Esperion has also submitted a marketing application for the approval of bempedoic acid in combination with ezetimibe, another cholesterol-lowering drug. The FDA is expected to announce its final decision by Feb. 26.
Shares of the company were up marginally in trading after the bell.
(Reporting by Dania Nadeem, Saumya Sibi Joseph and Trisha Roy in Bengaluru; Editing by Shailesh Kuber and Anil D’Silva)