Jagged Little Pill: With Merck's Oral PCSK9 Inhibitor, Does LDL-C Care Change?
Merck says the daily pill lowered LDL by nearly 60% in late-stage trials and offers a first oral option for patients who need more cholesterol reduction.
- On Thursday, the FDA approved Merck's Lipfendra, the first oral PCSK9 inhibitor, for reducing high LDL-cholesterol and heterozygous familial hypercholesterolemia alongside diet and exercise.
- Previous PCSK9 inhibitors, including Amgen's Repatha and Regeneron Pharmaceuticals' Praluent, require injections every two or four weeks; Merck's drug uses a macrocyclic peptide structure enabling oral administration.
- Late-Stage clinical trials demonstrated the daily pill lowered LDL levels by an average of nearly 60%, addressing what RBC Capital Markets analyst Trung Huynh calls a major unmet need: an estimated 70% of high-risk patients remain undertreated.
- Merck expects Lipfendra to become available in coming weeks at $315 for a 30-day supply, though patients must take the medication on an empty stomach and refrain from eating for 30 minutes.
- Last December, the FDA awarded Lipfendra a Commissioner's National Priority Review Voucher to accelerate its path to market, while competitors like Eli Lilly develop one-time gene therapies designed to permanently silence the PCSK9 protein.
12 Articles
12 Articles
Jagged Little Pill: With Merck's Oral PCSK9 Inhibitor, Does LDL-C Care Change?
The story of PCSK9 is an archetypal chapter from the precision medicine book of successes. It opens with the discovery of rare genetic variants that naturally lower PCSK9 activity, showing how well lowering low-density lipoprotein cholesterol (LDL-C) protects against cardiovascular disease. That discovery leads to a renaissance in lipid management, with monoclonal antibodies, RNA-based therapies, and experimental gene-editing methods to permanen…
Merck’s Lipfendra (Enlicitide): The First Oral PCSK9 Inhibitor Arrives
By Peter A. McCullough, MD, MPH It has been several years since the introduction of a new oral drug to lower cholesterol. However, the injectable market has become crowded with more choices for those needing cholesterol-lowering. Merck’s new drug will almost certainly be disruptive in the marketplace. 💊 Merck’s Lipfendra: The First Oral PCSK9 Inhibitor...
According to the Wall Street Journal, the FDA has given the "green light" in the US to a new pill that appears more effective than statins, but whose price will exceed $10 each.
First Cholesterol-Lowering Pill to Replace PCSK9 Injections Gets US Nod
The US FDA has given the green light to the world's first oral PCSK9 inhibitor, a groundbreaking medication that promises a convenient once-daily tablet alternative to injections for managing high cholesterol in adults, particularly those with genetic variations. When combined with other treatments, this innovative drug has shown a significant reduction in bad cholesterol levels. Unfortunately, it may not be available in India right away.
Merck Pill Becomes First Oral Option in Growing Class of Cholesterol-Lowering Drugs
Merck’s Lipfendra is the first FDA-approved pill in the class of cholesterol-lowering drugs called PCSK9 inhibitors. While peptides are typically injected, Lipfendra is a macrocyclic peptide designed for formulation as an oral drug.
FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients
WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-its-kind pill that can drastically reduce cholesterol in a way that’s previously only been available with expensive, injectable drugs. The drug from Merck was OK’d on Thursday for patients with artery-clogging cholesterol that persists even after taking statins, the standard medications for cutting heart attack risk. Merck will market its pill under the brand name Lipfend…
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