Once-daily pill marks new era in cholesterol treatment as FDA approves Merck's oral PCSK9 inhibitor

The FDA has approved enlicitide (Lipfendra), the first oral PCSK9 inhibitor for lowering cholesterol, marking a major shift from the injectable therapies that have dominated this class of drugs. Merck's once-daily 20 mg pill is approved as an adjunct to diet and exercise to reduce LDL cholesterol in adults with high cholesterol or heterozygous familial hypercholesterolemia, according to healio.com and ajmc.com.

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healio.comFDA approves Lipfendra, the first oral PCSK9 inhibitor, to lower LDLajmc.comFDA Approves Enlicitide, First Oral PCSK9 for High Cholesterol

"beating AstraZeneca in the race to develop more accessible treatment options."

BioSpaceMerck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor

That race underscores the long-standing demand for a simpler alternative. While existing injectable PCSK9 inhibitors are highly effective, their need for regular shots has limited patient uptake. Merck's oral formulation could expand access to a broader population, BioSpace reported.

"shown that a controversial program to speed up drug reviews may still be alive."

biopharmadive.comMerck wins first approval of a PCSK9 cholesterol pill

The approval also draws attention to the FDA's use of an accelerated review pathway designed to get treatments to patients faster. The agency's decision suggests that program, which has faced scrutiny, remains a viable option for certain drug applications, according to biopharmadive.com. MedPageToday and weareiowa.com characterized the approval as a "first-of-its-kind" milestone for cholesterol management.

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weareiowa.comFDA approves first-of-its-kind cholesterol pillMedPageTodayFDA Approves First PCSK9 Inhibitor Pill for Cholesterol

Merck, known as MSD outside the United States, now holds the first FDA approval for an oral PCSK9 inhibitor, as pharmaphorum confirmed. The pill offers a new option for patients who cannot tolerate statins or need additional LDL lowering, though it is intended as an add-on therapy, not a replacement for diet and exercise.

pharmaphorumMSD gets first FDA okay for oral PCSK9 cholesterol drug