Merck Gets FDA Nod for New Cholesterol Pill, Because Statins Weren't Cutting It
Merck gets FDA approval for a new daily cholesterol pill that works better than statins and doesn't make your muscles ache, but will cost you $10.50 a day before insurance gets involved.
Drug giant Merck announced Thursday that the FDA has approved a daily pill called Lipfendra, an alternative to statins for treating high LDL levels - the so-called bad cholesterol that keeps cardiologists in business. Lipfendra is a PCSK9 inhibitor, a class of drug that previously required injections, because apparently taking a pill would have been too easy.
For decades, statins have been the go-to therapy for high cholesterol, and they remain the most prescribed medication in the US. But statins come with occasional side effects like muscle aches, and sometimes they just don't drop cholesterol enough to hit recommended levels - a problem for the 70% of patients who, according to Merck's Dr. Paja Banka, are not reaching their LDL goal. "Seventy per cent of patients are not getting to their LDL goal," she said, which is either a damning statistic or a great marketing pitch, depending on your perspective.
The new pill is intended to be taken alongside statins, though in some cases it can go it alone. Its side effects, Banka said, "were like the placebo," which is medical-speak for "we didn't find anything nasty." No muscle aches were reported, which is a nice change of pace from the statin experience.
Heart disease remains the leading cause of death in the US, and high LDL levels are known to cause atherosclerotic cardiovascular disease (ASCVD), or plaque buildup - the cardiovascular equivalent of a clogged drain. Guidelines from the American College of Cardiology and the American Heart Association, issued in March, recommend LDL levels below 100 mg/dL for most, with lower targets for high-risk patients: below 70 mg/dL for those at high risk, and below 55 mg/dL for those with ASCVD who are at very high risk. Clinical trials suggest Lipfendra can bring LDL "down to 50 or 60 or even lower," according to The New York Times, which is great news for anyone who wants their cholesterol numbers to look like a blood pressure reading.
Merck says the drug will be available within weeks, with a list price of $10.50 a day, or over $300 a month. But don't panic - they expect out-of-pocket costs to be lower for many patients, because nothing says "affordable healthcare" like a $300 monthly copay.
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