FDA approves 1st-of-its-kind pill to reduce cholesterol
The pill is meant to accompany a healthy diet and exercise.
The Food and Drug Administration (FDA) approved on Thursday a first-of-its-kind oral option that can lower "bad" LDL cholesterol with a daily pill instead of a shot.
The new pill manufactured by Merck, called Lipfendra, is taken once a day as an accompaniment to a healthy diet and exercise.
The pill works by inhibiting a protein called PCSK9, which normally stops the body from clearing LDL from the blood.
Previously, PCSK9 inhibitors were only available as costly, biweekly or monthly injections. Lipfendra will carry a list price of about $300 a month, compared to roughly $500 for comparable injectables.
The American Heart Association estimates that one in four adults has high LDL cholesterol. Left unchecked, it can cause fatty deposits to build up in artery walls, raising the risk of heart attack, stroke and other cardiovascular disease.
"Lowering LDL is one of the most effective tools we have in preventive cardiology because it directly targets a major driver of heart disease," said Dr. Jeffrey Berger, the director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart.
The FDA's decision was based on two late-stage trials in which Lipfendra cut LDL levels by 56% to 59% compared to a placebo. Those results held up across different patient groups, including people with a genetic form of high cholesterol called familial hypercholesterolemia.
Experts say this gives patients who can't or won't take injectables a new option.
"The oral format could broaden adoption because many patients and physicians are more comfortable with pills than injections," explained Dr. William Soliman, founder and CEO of the Accreditation Council for Medical Affairs, an accrediting body that oversees the life sciences industry.
Lipfendra also serves as a powerful add-on therapy for patients already taking statins who still need help reaching their target cholesterol goals, according to experts.
The drug is expected to hit pharmacies in the coming weeks, but patients will need to check with their insurance to see what they'll actually pay.
"Ultimately, this approval expands our ability to personalize cholesterol treatment and help more people achieve the LDL levels that can better protect their cardiovascular health," Berger said.
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