FDA OKs drug that lowers cholesterol in a new way

Weight loss drug Belviq pulled

TRENTON, NJ, Feb 22, (AP): US 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.

“This is a nice alternative” to statins, but those medicines will still be 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 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.

Valuable

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.

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

The new drug “would be valuable to add to treatment” for patients who can’t get their 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 not involved in the research, estimated 10% to 15% of his patients might be eligible for Nexletol.

In company-funded studies, common Nexletol side effects included high blood pressure and muscle and joint pain. Serious side effects include tendon rupture. Women who are pregnant or breast-feeding should not take Nexletol because of possible harm to the baby, the FDA said.

In one study of more than 2,200 patients, there were several more deaths from heart problems in the Nexletol group than among those given placebo pills. Patel said that’s likely just a random imbalance, not a big concern.

The company has a large study underway to see whether Nexletol can lower the risk of heart attacks and other problems, not just cholesterol. Results are expected late in 2022. The company estimates Nexletol could be appropriate for up to 18 million Americans and more than 100 million people in other countries.

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

Adding Nexletol to that statin during the study cut his bad cholesterol even more.

“It definitely made a difference,” Valant said.

Weight loss:

The maker of a weight loss drug pulled it from the market last Thursday at the request of federal regulators, who said it posed a slight increased risk of cancer.

Japan’s Eisai Inc said it was voluntarily withdrawing the drug, Belviq. However, the company said in a statement that it disagreed with the US Food and Drug Administration’s interpretation of new data on the drug’s safety and still believes Belviq’s benefit outweighs the risk.

The FDA said patients should stop taking Belviq immediately, dispose of leftover pills and contact their doctor for advice on alternatives. The agency also told doctors to notify their patients to stop taking the drug.

Safety

Belviq was approved in 2012, roughly the same time that a couple other promising weight loss drugs hit the market. None became the blockbusters they were expected to be, but they offered an option for the many people struggling with excess weight or obesity and related health problems.

Belviq was the first drug proven to help people lose weight and keep it off for several years without raising their risk for heart problems. That was the conclusion of a five-year, 12,000-patient study of the drug’s heart safety, which the FDA required Eisai to conduct as a condition of approval.

A recently completed FDA analysis of the data from that study showed 7.7% of participants who took Belviq were diagnosed with cancer, slightly more than the 7.1% who developed cancer in a comparison group given dummy pills.

There was a range of cancers, with pancreatic, colorectal and lung cancer reported more often in the patients who took Belviq, the FDA said.

The agency said no special cancer screening is needed for anyone who took Belviq. It noted the increased risk was only seen after extended use of the drug.

Eisai said its assessment is that Belviq has more benefit than risk for its intended patients. It’s specifically approved for adults with a body mass index of 30 and adults with a BMI of 27 who have other conditions that carry heart risks, such as high blood pressure, high cholesterol or Type 2 diabetes.