Tag: drug

❓ WHAT HAPPENED: The Food and Drug Administration (FDA) has approved a new pill that lowers cholesterol.

📺 DETAIL: On Thursday, the FDA approved Lipfendra, a new cholesterol-lowering pill. Developed by Merck, a German pharmaceutical multinational, Lipfendra belongs to the PCSK9 inhibitor class of medications. PCSK9 is a liver-produced enzyme that regulates blood cholesterol levels. The pill is the first of its kind, as previous PCSK9 inhibitors were only available as injections. The pill is designed to be taken daily. Lipfendra is intended to help patients with hypercholesterolemia, or high LDL, known widely as “bad” cholesterol. According to clinical trials, the pill can reduce “bad” cholesterol levels by up to 60 percent over the course of 24 weeks. The clinical trials also revealed that the drug worked on patients already taking statins or other cholesterol-lowering drugs, as well as people suffering from heterozygous familial hypercholesterolemia, a genetic condition that causes high cholesterol. “It’s a very effective reduction… Whatever amount of lowering you get from the statin, you get more lowering by adding a PCSK9 on top of the statin, and vice versa,” said Dr. Steven Nissen, Chief Academic Officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic.

🎯 IMPACT: The approval of Lipfendra offers a new option for millions of Americans struggling to manage high cholesterol. According to the American Heart Foundation, approximately one in four U.S. adults. The pill will cost $10.50 per day, but Merck expects out-of-pocket costs to be lower for most patients. This represents another significant decision by the FDA within just a matter of months. Last month, the administration relaxed regulations around testosterone replacement therapy. At the start of the year, the FDA issued a review of a potentially carcinogenic food additive. In October 2025, the FDA announced a recall of blood pressure drugs due to cancer risk concerns. The latest announcement coincides with the release of new guidelines from major medical organizations stating that even those not at risk of heart disease should seek to lower their “bad” cholesterol levels.