FDA OKs new cholesterol drug

TRENTON, N.J. — U.S. regulators on Friday approved a new type of cholesterol-lowering drug aimed at millions of people who can’t tolerate — or don’t get enough help from — widely used statin pills like Lipitor and Crestor.

The Food and Drug Administration approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and people who have heart disease and need to further lower their bad cholesterol. The daily pill is to be taken in conjunction with a healthy diet and the highest statin dose patients can handle, the FDA said.

High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems. Studies showed that Nexletol could lower LDL by about 25% when taken alone and by an additional 18% when combined with a statin.

Millions of people take cheap, generic statins, but the medicines don’t lower LDL cholesterol enough for many patients and others experience side effects such as muscle pain. Other options include Zetia pills, also sold in generic form as ezetimibe for about $13 to $50 a month.

Far fewer patients use Repatha and Praluent, newer drugs that cost $6,000 or more a year. Insurers often restrict coverage of those medicines, which are shots patients give themselves once or twice a month.

Esperion, based in Ann Arbor, Michigan, did not immediately disclose the drug’s list price but previously said it planned a price of about $300 per month. Nexletol, also known as bempedoic acid, should be available in late March, the company said.