The U.S. Food and Drug Administration (FDA) has officially approved the new oral cholesterol-lowering drug Lipfendra, developed by Merck. The approval, granted on July 16 Eastern Time, marks the global authorization of the first oral PCSK9 inhibitor, a class of drugs previously limited to subcutaneous injections, providing a new daily treatment option for patients with high cholesterol.

Previously, all available PCSK9 inhibitors required administration via injection every two weeks or monthly, with their high cost and inconvenience limiting widespread clinical adoption. The newly approved Lipfendra is a 20mg tablet taken once daily. It works by inhibiting the PCSK9 protein, helping the body clear low-density lipoprotein cholesterol from the bloodstream. Data from two key Phase III clinical trials indicate that, when combined with a healthy diet and exercise, the drug successfully reduced patients' LDL-C levels by 56% to 59%, demonstrating efficacy comparable to injectable formulations.

The medical community has responded positively to this development. Dr. Jeffrey Berger, Director of the Center for Cardiovascular Disease Prevention at NYU Langone Health, emphasized that lowering bad cholesterol is central to preventing cardiovascular disease, and the approval of an oral formulation will significantly expand the scope for personalized clinical treatment. William Soliman, founder and CEO of the Accreditation Council for Medical Affairs, noted that patient and physician acceptance of oral medications is significantly higher than for injections, which should greatly improve patient adherence to treatment.

High cholesterol is a key risk factor for cardiovascular events such as heart attacks and strokes, affecting approximately one-quarter of the adult population. Lipfendra is expected to become available in U.S. pharmacies in the coming weeks. Its projected price is $315 per month, or approximately $10.50 per day. This represents a potential cost reduction of up to 40% compared to the roughly $500 per month for comparable injectable therapies. However, the drug's accessibility for a broad patient population will still depend on reimbursement rates and coverage policies set by commercial health insurance providers in various countries.