Merck Receives FDA Approval for First Oral PCSK9 Inhibitor, Lipfendra

MRK won U.S. FDA approval for Lipfendra (enlicitide), the first and only once-daily oral PCSK9 inhibitor cleared to lower LDL-C in adults with hypercholesterolemia. The approval beats AZN to market with the first PCSK9 pill, a class that until now existed only as injectable antibodies.

In the CORALreef Lipids trial, Lipfendra cut LDL-C by 56% versus placebo at week 24, and by 59% in the CORALreef HeFH study in patients with heterozygous familial hypercholesterolemia. An oral formulation removes the injection barrier that has constrained PCSK9 uptake for more than a decade since the class emerged.

The launch gives Merck a potential blockbuster in a large cardiovascular market as it works to offset looming Keytruda patent exposure. Investors will watch payer coverage, pricing against injectable rivals, and how quickly cardiologists adopt the pill.

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