What did the FDA approve for Merck (NYSE:MRK)?

Merck (NYSE:MRK) received approval for once-daily Lipfendra 20 mg as an addition to diet and exercise for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. It is the first FDA-approved oral PCSK9 inhibitor.

How much did Merck (NYSE:MRK)’s Lipfendra lower LDL cholesterol?

Merck (NYSE:MRK) reported a 56% placebo-adjusted LDL-C reduction in CORALreef Lipids and a 59% reduction in CORALreef HeFH at week 24. A post-hoc analysis of CORALreef Lipids showed a 60% reduction.

What are the main side effects of Merck (NYSE:MRK)’s Lipfendra?

Merck (NYSE:MRK) reported that diarrhea affected 7% of Lipfendra-treated HeFH patients versus 2% on placebo, while dizziness affected 7% versus 4% in the published trial. Overall discontinuation rates were similar between treatment groups.

What does the cardiovascular outcome uncertainty mean for Merck (NYSE:MRK)’s Lipfendra?

Merck (NYSE:MRK) has shown that Lipfendra lowers LDL-C, but it has not yet established that the medicine reduces heart attacks, strokes or cardiovascular deaths. The CORALreef Outcomes trial is evaluating those results in more than 14,500 participants.

How is Merck (NYSE:MRK)’s Lipfendra different from existing PCSK9 treatments?

Merck (NYSE:MRK)’s Lipfendra is taken as a once-daily pill, while existing PCSK9 treatments such as Repatha and Praluent are administered by injection. Lipfendra also works by blocking PCSK9 from reducing the liver’s LDL receptors.

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Merck wins FDA approval for 56% LDL cut

Written by Jon CuthbertPublished Jul 16, 2026, 11:13 AM

Merck received FDA approval for Lipfendra 20 mg, the first oral PCSK9 inhibitor for adults with hypercholesterolemia.
Merck shares were up 2.3% at $123.61 following the FDA decision.
Merck is continuing a 14,500-patient outcomes trial to determine whether Lipfendra reduces cardiovascular events.

Merck (NYSE:MRK) received FDA approval for Lipfendra 20 mg after a Phase 3 trial showed a 56% LDL-C reduction versus placebo.

The CORALreef HeFH trial showed a 59% placebo-adjusted LDL-C reduction among adults with inherited high cholesterol after 24 weeks.

“This is a pivotal moment as we bring the first U.S. FDA-approved oral PCSK9 inhibitor to adults with high LDL-C,” said Merck Research Laboratories President Dr. Dean Y. Li.

Diarrhea occurred in 7% of Lipfendra patients versus 2% on placebo, while its effect on heart attacks and deaths remains unproven.

Lipfendra gives Merck an oral alternative to injectable PCSK9 treatments as the company prepares for Keytruda biosimilar competition from 2028.

The FDA previously placed enlicitide in its National Priority Voucher program, while Merck continues the CORALreef Outcomes cardiovascular study.

Merck wins FDA approval for 56% LDL cut

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