The FDA has approved Lipfendra, Merck’s once-daily pill that targets the PCSK9 protein to lower LDL cholesterol. It is the first oral drug in this class — a category previously limited to injectable treatments.
I'm a cardiologist. Today the FDA approved something I've been waiting two decades for: the first oral PCSK9 inhibitor in history. A once-daily pill — Lipfendra (enlicitide), from Merck — that lowers LDL as powerfully as the injections we've relied on.
This is one of those days…
— Afshine Emrani MD FACC (@afshineemrani) July 16, 2026
Merck stock (MRK) was in focus Wednesday following the announcement, as investors weighed the commercial potential of a drug analysts expect to generate more than $5 billion in peak annual sales.
Lipfendra reduced bad cholesterol by up to 60% over six months in adults with or at risk for atherosclerotic cardiovascular disease. That’s a meaningful jump beyond what statins alone can deliver.
The list price is set at $10.50 per pill, or $315 for a 30-day supply. That’s well below the $500–$600 monthly cost of injectable alternatives like Amgen’s Repatha. Insured patients are expected to pay less out of pocket.
Repatha already pulls in $3 billion a year for Amgen, giving a sense of the market Merck is now entering with a more convenient, pill-based option.
Merck is under pressure to build its next revenue engine. Its cancer drug Keytruda, currently a blockbuster, will face lower-cost competition within the next few years. Lipfendra is one of the drugs the company is counting on to fill that gap.
The FDA approved Lipfendra under its Commissioner’s National Priority Voucher program, which cut the review timeline from six to twelve months down to just one to two months — a fast track that reflects the drug’s perceived importance.
Merck CEO Robert Davis called the approval a potential shift in how the U.S. treats cholesterol. “The ability to meaningfully reduce LDL well above what you achieve on statins alone, in an easy-to-take pill, we think can really change care in the U.S.,” he said.
The CDC estimates about 47 million U.S. adults who could benefit from cholesterol medication are not currently taking it. A daily pill could lower the barrier to treatment for some of that group.
Affordability remains a real question. At $315 a month, cost could be a barrier for patients without solid insurance coverage. A KFF poll from March found 59% of Americans were worried about rising prescription drug costs — the highest level since the survey started in 2018.
To address this, Merck plans to list Lipfendra on TrumpRx.gov, a government platform offering discounted drugs. A price for that channel has not yet been announced.
Lipfendra can be taken alongside statins, and Merck is running an additional study to determine whether the drug also reduces heart attacks and strokes — not just cholesterol levels. Results from that trial could further define the drug’s commercial ceiling.
The drug is expected to be available to patients within weeks.
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