On Thursday, July 16th, 2026, the Food and Drug Administration (FDA) approved Lipfendra, a first-of-its-kind daily pill from Merck that drastically lowers cholesterol levels in high-risk patients. This oral medication works by inhibiting the production of PCSK9 proteins in the liver, a mechanism previously targeted only by expensive injectable drugs from companies like Amgen.

Lipfendra is intended for patients whose artery-clogging cholesterol persists despite treatment with statins, the standard therapy for reducing heart attack risk. Statins reduce the liver’s cholesterol production, but many patients require additional intervention to sufficiently lower their LDL (low-density lipoprotein) cholesterol.

Merck, headquartered in Rahway, New Jersey, secured FDA approval based on two studies involving high-risk patients who added Lipfendra to their existing statin regimen. In one study of 3,000 patients, Lipfendra reduced LDL cholesterol by more than 55% after six months.

This approval marks the first noninjectable medication that blocks PCSK9, potentially improving patient access by addressing barriers such as high prices, insurance restrictions, and limited prescribing associated with injectable alternatives.

Sources note that Marty Makary, who resigned from the FDA in May 2026 amid pressures from drugmakers and patient groups, was involved in the agency during the period leading up to this approval.

Sources