Merck's cholesterol pill gets US FDA approval

Merck's recently approved cholesterol medication, Lipfendra, is the first oral PCSK9 inhibitor to gain FDA approval, marking a significant innovation in cholesterol treatment. The drug aims to manage hypercholesterolemia by blocking the PCSK9 protein, which regulates cholesterol levels. This approval is crucial for Merck as it seeks to diversify its portfolio after the upcoming patent loss of its blockbuster drug Keytruda in 2028. Clinical trials demonstrated that Lipfendra effectively lowers LDL cholesterol in diverse patient groups, with projections of peak sales reaching tens of billions. The FDA's endorsement comes under the National Priority Voucher program, expediting review due to its public health importance.

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The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, New Jersey

Item 1 of 2 The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo

[1/2] The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo Purchase Licensing Rights, opens new tab

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July 16 (Reuters) - Merck (MRK.N), opens new tab said on Thursday the U.S. FDA has approved its cholesterol pill, the first of its kind to receive the health regulator's nod, bolstering the drugmaker's efforts to diversify beyond its blockbuster ‌cancer treatment Keytruda.

Keytruda is set to lose key patent protections starting in 2028, exposing the company to competition from potential less expensive biosimilar versions of the drug.

Lipfendra is a drug intended to treat patients with hypercholesterolemia, which can be identified by elevated levels of LDL, the so-called "bad" cholesterol ⁠in the blood, often leading to plaque buildup in the arteries.

With the U.S. Food and Drug Administration's approval, Lipfendra, also called enlicitide, would become the first oral PCSK9 inhibitor to enter the market, offering an alternative to a class of cholesterol-lowering drugs long dominated by injectables.

It works by blocking PCSK9 protein, which plays a vital role in regulating cholesterol levels, while oral statins, an older type of cholesterol medicine, block an enzyme the liver uses to make cholesterol.

About ‌one ⁠in four adults in the U.S. have high LDL cholesterol, according to the American Heart Association.

The FDA's decision was based on two late-stage trials, which showed the once-daily pill significantly lowered LDL cholesterol in a broad range of patients, including those with ⁠familial hypercholesterolemia and those already taking statins.

The landscape for cholesterol-lowering drugs is currently dominated by PCSK9-inhibitor injectables such as Amgen's (AMGN.O), opens new tab Repatha, and Regeneron (REGN.O), opens new tab and Sanofi's (SASY.PA), opens new tab Praluent.

Lipfendra could have "peak sales ⁠potential of tens of billions of dollars," Scotiabank analyst Louise Chen had said ahead of the approval.

Merck's drug is a recipient of the FDA commissioner's ⁠National Priority Voucher program, which is intended to slash review periods of drugs that are critical to public health or national security.

Reporting by Padmanabhan Ananthan and Puyaan Singh in Bengaluru; Editing by Shailesh Kuber and Shilpi Majumdar

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Merck's cholesterol pill gets US FDA approval

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