FDA approves first new class of cholesterol drug in 20 years
For the first time in 20 years, the Food and Drug Administration (FDA) has approved a new class of cholesterol medication.
Alirocumab, also known by its brand name Praluent, reduced LDL cholesterol between 36 to 59 percent compared to a placebo during clinical trials, the FDA reported.
Currently, adults with a history of heart attack and stroke, or those needing additional help lowering their LDL are eligible for the new medication. The injectable drug will be available in two doses and cost $560 per injection, averaging $14,600 a year for treatment.
The drug was developed for patients with heterozygous familial hypercholesterolemia (HeFH), which is an inherited disease that causes people to have high levels of LDL in their blood beginning at birth. The disease puts them at risk of heart attacks at an early age, according to the National Human Genome Institute.
Men with the disorder are likely to have a heart attack in their early 40s and 50s and are 85 percent more likely to have a heart attack by age 60. Women who have the disorder are also at an increased risk of having a heart attack, but 10 years later than men (in their 50s or 60s).
“Praluent provides another treatment option for patients with HeFH, or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, in a news release. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”
According to the Center for Disease Control and Prevention, 73.5 million adults in the U.S. have high LDL. About 610,000 Americans die of heart disease every year – or one in every four deaths.
Medical experts believe that with more research this drug could be taken by more individuals, including those at high risk for heart disease, but who have not had a heart attack or stroke.
Photo credit: Regeneron Pharmaceuticals, Inc.
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Fantastic!
Readers may find discussion of this in Wall Street Journal today, 7/28/2015, quite interesting. It interviews cardiology experts who point out that many patients who think they can’t tolerate statins can actually tolerate them– if they are re-tried slowly at low doses. Also, physicians may be interested where the WSJ article mentions that the American College of Cardiology has issued a smartphone app enabling physicians and patients to figure out strategies together for determining if a patient is truly intolerant of statins.
Statins are much less expensive. Additionally, it is not yet clear that this expensive new drug class actually reduces heart attacks for large numbers of people without HeFH — they FDA will be reviewing those studies when completed in 2017.
This drug offers so much hope to the patients we have treated (some for years) who we cannot get their LDL cholesterol levels down to the goals that are appropriate. The clinical studies behind this product are double blind, placebo controlled, randomised studies and the placebo is maximally tolerated statins PLUS any other lipid lowering therapies. This product will gain an additional 40-60% LDL lowering on top of statins.
The patients we see every day who have clinical ASCVD and still have goals unmet can now have an opportunity to meet these goals. We as clinicians need to evaluate many patients for this new class of compounds. Our patients deserve it.