FDA approves 1st-of-its-kind pill to reduce cholesterol

The Food and Drug Administration approved a new oral medication called Lipfendra. This drug provides a daily option for patients who need to lower their LDL cholesterol levels. Merck manufactures the pill, which acts by inhibiting the PCSK9 protein. This protein prevents the body from clearing LDL from the blood. Prior to this approval, options for PCSK9 inhibition were restricted to biweekly or monthly injections.

Patients take the medication once per day in addition to following a healthy diet and regular exercise. The FDA based this decision on two late-stage clinical trials. Data showed the drug reduced LDL levels by 56% to 59% compared to a placebo. These results remained consistent across patient groups, including individuals with genetic conditions like familial hypercholesterolemia.

Cardiologists view this oral option as a major step for preventive medicine. It offers an alternative for patients who cannot or will not use injectables. The list price is set at approximately $300 per month, which is lower than the $500 cost for comparable injectable treatments.

Lipfendra is expected to reach pharmacies in the coming weeks. Doctors see the pill as a useful add-on for patients already taking statins who struggle to reach their target cholesterol goals. Patients should consult their healthcare providers and insurance plans to determine coverage and out-of-pocket expenses.