On Thursday, July 16, the FDA approved Lipfendra, a once-daily cholesterol-lowering medication from Merck. According to a Reuters report, it's the first pill in a class of drugs known as PCSK9 inhibitors, which until now have only been available as injectable medications, making Lipfendra the first oral option available in the U.S. PCSK9 inhibitors work by blocking a protein that can raise LDL cholesterol levels in the blood.
Lipfendra is approved for people with hypercholesterolemia, including inherited forms of the condition that cause elevated levels of low-density lipoprotein, or LDL, often called "bad" cholesterol. High LDL cholesterol can contribute to plaque buildup in the arteries and increase the risk of heart disease. About one in four U.S. adults has high LDL cholesterol, according to the American Heart Association.
Merck plans to position Lipfendra primarily as an add-on treatment for patients who are already taking cholesterol-lowering medications, such as statins, but still haven't reached their recommended LDL cholesterol goals.
"Seventy percent of those patients treated with those therapies are still not achieving guideline recommended goals. We believe this is the opportunity," Merck Executive Vice President Brian Foard told the outlet.
The FDA's approval was based on two late-stage clinical trials that found the once-daily pill lowered LDL cholesterol by nearly 60% in patients with hypercholesterolemia.
The company said Lipfendra will carry a list price of $10.50 per day, or about $315 per month, and is expected to become available within the next few weeks.
An analyst told Reuters the new pill could help address a longstanding challenge for patients who are reluctant to take injections.
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