FDA clears first-of-its-kind cholesterol pill

Taking cholesterol medicine may soon feel less like a doctor’s order and more like your old daily Flintstones vitamin ritual.

The FDA late last week approved Lipfendra, the first daily pill on the market that blocks a key protein and allows the liver to extract and remove more “bad” LDL cholesterol from the bloodstream.

The once-daily tablet was approved after two clinical trials involving 3,200+ adults already taking the highest statin dose they could tolerate to treat high LDL levels.

• Among patients with cardiovascular disease or at high risk for it, LDL cholesterol fell 56% after 24 weeks on Lipfendra compared to a placebo.
• In adults with an inherited form of high cholesterol, LDL levels dropped by 59%.

A heartening development

The FDA’s approval represents a big shift for a class of drugs that, until now, has been dominated by injections costing upwards of $500/month. But Lipfendra, which goes by the generic name enlicitide, is expected to cost ~$315/month.

Merck hopes taking this medication becomes as routine as taking a statin, with primary care doctors able to prescribe it in addition to cardiologists.

Big picture: About 1 in 4 US adults has high LDL cholesterol, according to the American Heart Association.