The U.S. Food and Drug Administration (FDA) has approved Merck's new cholesterol-lowering pill, Lipfendra, marking the first oral treatment in a class of drugs that primarily consists of injections. The approval, announced Thursday, could potentially increase access to cholesterol medication for individuals at risk of heart disease.

Lipfendra, also known as enlicitide, is designed to treat hypercholesterolemia, including hereditary forms of the condition. These conditions lead to elevated levels of low-density lipoprotein (LDL) cholesterol, commonly referred to as "bad" cholesterol, which can contribute to plaque buildup in the arteries. According to the American Heart Association, approximately one in four adults in the United States have high LDL cholesterol.

The newly approved pill functions by blocking a protein called PCSK9. High levels of PCSK9 are linked to increased cholesterol and cardiovascular disease. While injectable PCSK9 inhibitors have been available for years, Lipfendra offers an oral alternative.

Merck plans to market Lipfendra as an add-on therapy for patients already taking cholesterol-lowering treatments such as statins. "Seventy percent of those patients treated with those therapies are still not achieving guideline recommended goals. We believe this is the opportunity," said Merck Executive Vice President Brian Foard.

Analysts suggest that the pill's convenience may address barriers to current treatments. "Despite a decade of approved injectable options, an estimated 70% (and more) of eligible high-risk atherosclerotic cardiovascular disease patients remain undertreated; driven by injection aversion, prior authorization burden, and limited specialist access in primary care," noted RBC Capital Markets analyst Trung Huynh. Huynh projects Lipfendra could achieve peak sales of approximately $5 billion by 2034.

The FDA's decision was informed by two late-stage clinical trials demonstrating that the once-daily pill reduced LDL cholesterol by nearly 60% in patients with hypercholesterolemia. Merck has stated that an ongoing clinical trial is investigating the drug's impact on cardiovascular morbidity and mortality.

Lipfendra is set to be available in the coming weeks with a list price of $10.50 per day, equating to about $315 per month. This oral treatment joins existing PCSK9-inhibitor injectables on the market, such as Amgen's Repatha and Regeneron and Sanofi's Praluent.

Merck shares saw a 4% increase in morning trading following the FDA's announcement.