Associated Press February 21, 2020 03:58 PM
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.
"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.
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.
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