FDA approves drug that lowers cholesterol in a fresh way

U.S. regulators have approved a fresh kind of cholesterol-lowering drug targeted at millions of people who can't tolerate - or do not get enough help from - trusted statin pills like Lipitor and Crestor.

THE MEALS and Drug Administration approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and persons who have cardiovascular disease and have to further lower their bad cholesterol. The daily pill is usually to be used conjunction with a healthy diet plan and the highest statin dose patients can handle, the FDA said.

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

“This is a nice alternative” to statins, but those medicines it's still the first choice, said Dr Christie Ballantyne, Baylor College of Medicine's cardiology chief. He consults for Esperion and helped test the drug.

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

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

Esperion, located in Ann Arbor, Michigan, didn't immediately disclose the drug's list price but previously said it planned a price of about $300 per month. Nexletol, generally known as bempedoic acid, ought to be obtainable in late March, the business said.

It works in the liver by blocking an enzyme had a need to make LDL. Statins also block cholesterol production in the liver, however in a different way, so the drugs together can reduce LDL more.

The brand new drug “would be valuable to add to treatment” for patients who can't obtain LDL down enough with existing drugs or can't afford the injected ones, Duke Heart Center co-director Dr Manesh Patel said. Patel, who was simply not involved in the research, estimated 10% to 15% of his patients could be eligible for Nexletol.

In company-funded studies, common Nexletol unwanted effects included high blood pressure and muscle and joint pain. Serious unwanted effects include tendon rupture. Women who are pregnant or breast-feeding shouldn't take Nexletol due to possible harm to the baby, the FDA said.

In one study greater than 2,200 patients, there have been several more deaths from heart disease in the Nexletol group than among those given placebo pills. Patel said that's likely simply a random imbalance, not a big concern.

The business has a sizable study underway to see whether Nexletol can lower the risk of heart attacks and other problems, not simply cholesterol. Email address details are expected late in 2022. The business estimates Nexletol could possibly be befitting up to 18 million Americans and a lot more than 100 million people in other countries.

Michael Valant, 71, of League City, Texas, took Nexletol for approximately 19 months in one study. Valant, a retired global supply chain manager, had a heart bypass procedure greater than a decade ago and took a statin for years, nonetheless it wasn’t helping enough.

Adding Nexletol compared to that statin through the study cut his bad cholesterol a lot more.

“It definitely made a notable difference,” Valant said.