AstraZeneca pursues oral PCSK9 pill to compete with Merck's Lipfendra
AstraZeneca developing competing daily PCSK9 pill to rival Merck's Lipfendra.
Event / Science
Merck Lipfendra Cholesterol Drug Approval
FDA approves Merck's Lipfendra (enlicitide), the first oral PCSK9 inhibitor for cholesterol reduction. The once-daily pill demonstrated 55-60% LDL cholesterol reduction in trials and costs $315 monthly, significantly less than existing injectable alternatives.
1 reported locations
Daily activity
0 articles0 articles
2026-08-15 to 2026-11-12 · UTC publication dates
Coverage begins 17 Jul, 01:01 UTC
Follow the documented timeline or explore the related reporting.
What happened
Lipfendra priced at $10.50 per day, significantly lower than injectable alternatives
Merck set the list price of Lipfendra at $10.50 per day based on a 30-day supply, equating to approximately $315 monthly. This represents a substantial cost reduction compared to existing injectable PCSK9 inhibitors such as Amgen's Repatha and Regeneron/Sanofi's Praluent, which cost $500 to $600 per month. The drug is also eligible for discounts through TrumpRx.gov and certain insurance plans.
Merck received FDA National Priority Voucher for drug review acceleration
Lipfendra was selected for the FDA commissioner's National Priority Voucher program, which is intended to expedite review periods for drugs critical to public health or national security.
FDA approves Merck's enlicitide pill for cholesterol reduction
The Food and Drug Administration approved enlicitide (brand name Lipfendra), a once-daily oral pill manufactured by Merck on July 16. The pill is designed to reduce cholesterol levels by blocking PCSK9 proteins that regulate cholesterol receptors in the body. This is the first FDA-approved oral PCSK9 inhibitor; previous PCSK9 inhibitors were injectable medications.
AstraZeneca testing competing daily PCSK9 inhibitor pill in phase 3 trial
AstraZeneca is conducting phase 3 clinical trials of its own daily pill targeting low-density lipoprotein cholesterol, following favorable results from earlier testing stages.
Clinical trials show Lipfendra reduces LDL cholesterol by 55-60 percent
Two randomized, double-blind, placebo-controlled trials involving approximately 3,200 adults with severe hypercholesterolemia demonstrated the drug's efficacy. One trial showed a 56 percent drop in LDL cholesterol levels compared to placebo, while the other showed a 59 percent drop. Participants were also taking statins. Adverse events were mostly similar between drug and placebo groups, though diarrhea and dizziness occurred more frequently in drug recipients in one trial.
Approximately 47 million Americans take cholesterol medications
About 47 million people in the United States are on medication to control cholesterol levels, with most taking statins. Additionally, approximately 25 percent of U.S. adults have high low-density lipoprotein (LDL) cholesterol levels, according to the American Heart Association.
Read the coverage
2 alternative perspectives
Merck's Lipfendra wins FDA approval as oral cholesterol breakthrough
FDA approves Merck's Lipfendra oral cholesterol pill, reducing LDL by 55-60% at $10.50 daily.