FDA approves first daily pill to drastically lower cholesterol in high-risk patients

The US Food and Drug Administration has approved Merck's Lipfendra, a first-of-its-kind daily pill that reduces LDL cholesterol by more than 50% in high-risk patients by blocking the PCSK9 protein — a mechanism previously available only via injectable drugs. Source: AP News

Mechanism and Efficacy

Lipfendra is a PCSK9 inhibitor that helps the liver remove more LDL, or "bad," cholesterol from the blood. In two clinical trials, patients who added the pill to standard statin therapy saw their LDL levels drop by 55% to 59% after six months compared with placebo. Source: AP News The drug's side effects — including dizziness and diarrhea — were similar to those of a placebo, and it must be taken on an empty stomach. Source: AP News The Guardian notes that the pill can be used "in conjunction" with statins, and in some cases alone, with minimal muscle aches. Source: The Guardian

Cost and Availability

Merck has set a list price of $10.50 per day (over $300 a month), though out-of-pocket costs are expected to be lower for many patients. Source: The Guardian The drug is expected to be available within weeks. Source: The Guardian The approval comes under the FDA's ultra-fast review pathway, created by former FDA chief Dr. Marty Makary. Source: AP News