A decade after PCSK9 inhibitors first entered the market, the drug class has yet to fully meet the high commercial expectations that initially surrounded it at the time of arrival. Although therapies such as Praluent from Sanofi, along with Amgen’s Regeneron and Repatha, have consistently outperformed statins at lowering low-density lipoprotein (LDL) cholesterol, widespread adoption was slowed in the early years by high costs and limited patient access.
Merck is now introducing a different approach with enlicitide, which received the FDA nod on Thursday and will be marketed under the brand name Lipfendra. The macrocyclic peptide is the first orally administered PCSK9 inhibitor to reach the market.
The FDA approved a once-daily 20 mg dose of Lipfendra for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). The treatment is indicated to lower LDL cholesterol in patients whose elevated cholesterol levels place them at increased risk of serious cardiovascular events such as heart attack and stroke.
Unlike existing PCSK9 therapies, which require injections, Lipfendra offers patients an oral daily treatment that can be stored at room temperature. A Merck spokesperson said the medication will carry a list price of $315 per month before discounts and that the company intends to make it available through the direct-to-patient TrumpRx program. The spokesperson also noted that the list price is about 50% lower than that of other marketed PCSK9 therapies, including Novartis’ siRNA-based blockbuster Leqvio.
Having said that, one potential drawback is the dosing schedule. Patients must avoid food for eight hours before taking Lipfendra and wait another 30 minutes after dosing before eating, a regimen that could make it quite challenging for patients to adopt to over the long term.
Industry analysts project yearly peak sales of around $5 billion for Lipfendra. Merck is counting on the drug to help offset the expected decline in revenue once patent protection expires for Keytruda, the company’s leading cancer therapy, which generated nearly $32 billion and accounted for more than half of Merck’s total revenue last year.
Following the FDA approval, Merck shares rose approximately 3%. The approval was supported by results from two Phase 3 clinical trials. After 24 weeks of treatment, Lipfendra lowered LDL cholesterol by nearly 60% in patients with heterozygous familial hypercholesterolemia and by roughly 55% in those with high cholesterol, compared with placebo.
Merck said the studies also demonstrated reductions in atherogenic lipoproteins associated with atherosclerotic cardiovascular disease (ASCVD). However, the company noted that it has not yet been established whether Lipfendra can reduce the likelihood of cardiovascular illness or death, adding that a clinical outcomes trial is currently underway to answer that question.
The FDA granted approval through the Commissioner’s National Priority Voucher (CNPV) program, which shortens regulatory review timelines from the typical six to 12 months to approximately one or two months for medicines that align with national health priorities. The program generally includes therapies that represent meaningful innovation, address significant unmet medical needs, or strengthen domestic pharmaceutical manufacturing.
Merck has reached a significant milestone after receiving U.S. Food and Drug Administration (FDA) approval for Lipfendra. The regulatory decision represents another important achievement for Merck, reinforcing the company’s commitment to developing innovative therapies that address unmet medical needs and improve patient outcomes.
FDA Approval Marks a Major Achievement
The FDA’s approval of Lipfendra is a notable success for Merck, allowing the company to bring a new treatment option to eligible patients. Securing regulatory approval requires extensive clinical research demonstrating the medicine’s safety, efficacy, and overall benefit.
This achievement further strengthens Merck’s reputation as one of the world’s leading pharmaceutical innovators.
Expanding Merck’s Product Portfolio
Lipfendra adds another important product to Merck’s growing pharmaceutical portfolio. The approval may strengthen the company’s long-term growth strategy while supporting future investments in research, development, and additional clinical programs.
A broader portfolio also enables Merck to address a wider range of healthcare challenges across multiple therapeutic areas.
Years of Research and Clinical Development
The FDA decision follows years of investment by Merck in scientific research, clinical trials, manufacturing, and regulatory preparation. Successfully moving a medicine from discovery through approval requires rigorous testing and collaboration with healthcare professionals and regulatory agencies.
The approval highlights Merck’s continued focus on advancing innovative medicines through evidence-based research.
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