Merck announces FDA approval for new daily cholesterol pill Lipfendra
8 reported
Drugmaker Merck announced Thursday that the U.S. Food and Drug Administration has approved Lipfendra, a daily pill designed to lower high LDL cholesterol levels. The medication is a version of a drug class known as PCSK9 inhibitors, which previously required injection. Merck stated that the new drug should be available within weeks. Dr. Puja Banka, a Merck associate vice-president and pediatric cardiologist, said 70% of patients do not reach their LDL goal with statins alone. She noted that side effects in trials were minimal and comparable to a placebo. The list price is set at $10.50 per day, though Merck expects out-of-pocket costs to be lower for many patients.
What’s reported
Merck announced FDA approval for Lipfendra, a daily pill for high LDL cholesterol.
Lipfendra is a version of a PCSK9 inhibitor, previously only available as an injection.
Dr. Puja Banka stated that 70% of patients do not reach their LDL goal with statins.
Side effects in trials were described as "like the placebo" with no muscle aches.
The drug is intended to be taken with statins, though it can be used alone in some cases.
Merck said the drug should be ready within weeks.
The list price is $10.50 per day, or over $300 per month, with lower out-of-pocket costs expected for many patients.
The New York Times reported clinical trials showed the drug can lower LDL to 50 or 60 or lower.
Key figures
Dr. Puja Banka, associate vice-president for global clinical development at Merck and a pediatric cardiologist
Merck (drugmaker)
FDA (U.S. Food and Drug Administration)
American College of Cardiology
American Heart Association
The New York Times
Sources: The Guardian
