Clinical trials show substantial LDL reductions with Lipfendra, including roughly a 55% drop after six months in one study and about a 59% drop in another, with effects persisting modestly over a year.

In trials, Lipfendra must be taken on an empty stomach and showed side effects such as dizziness and diarrhea at rates similar to placebo.

The approval comes as cardiovascular disease remains the leading cause of death in the U.S., underscoring the importance of lowering LDL cholesterol to reduce risk.

Price and access are potential barriers, with Lipfendra listed at $10.50 per day and insurance coverage varying by plan.

Public concern about rising prescription drug costs is evident in polling ahead of midterm elections, particularly among lower- and middle-income households.

Lipfendra, Merck’s first noninjectable pill, has been approved by the FDA to lower LDL cholesterol in high-risk patients who remain above goal despite statin therapy.

Cost-reduction options include paying cash via platforms like GoodRx, Cost Plus Drugs, or Amazon, and exploring Merck’s direct-to-consumer or government/manufacturer-assisted programs for discounted prescriptions.

Merck aims to diversify beyond Keytruda as patent cliffs approach in 2028, potentially increasing competition within its oncology lineup.

Lipfendra is expected to hit pharmacies in the coming weeks, with insurance coverage likely shaping out-of-pocket costs.

The new pill adds an oral option to the cholesterol toolkit, historically dominated by injectable PCSK9 inhibitors.

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The safety profile was largely comparable to placebo, with no major increases in adverse events for those with inherited high cholesterol.