First non-statin treatment approved by FDA in 20 years
The first non-statin treatment was cleared for sale in the USA in nearly 20 years, Reuters reports. Esperion Therapeutics Inc announced on Friday that U.S. health regulators approved its cholesterol-lowering drug.
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.
18% to 28% fall in LDL cholesterol
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.
Half of these patients are unable to keep their cholesterol in check despite being on statins while the other half cannot tolerate statin due to side effects such as muscle pain, nausea, and liver dysfunction, according to Еsperion.
A non-statin, once-a-day pill to combine with statin
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.