Sanofi’s New Hemophilia Drug Qfitlia Gains FDA Approval with Breakthrough Bimonthly Dosing

The U.S. Food and Drug Administration (FDA) has approved Qfitlia, a groundbreaking hemophilia treatment by French pharmaceutical giant Sanofi (NASDAQ: SNY). Designed for patients aged 12 and older with hemophilia A or B, with or without inhibitors, Qfitlia offers a major shift in treatment convenience with its bimonthly subcutaneous (under-the-skin) dosing—compared to weekly or even daily injections currently on the market.

This first-in-class therapy works by reducing antithrombin, a protein that delays blood clotting, and significantly lowers the risk of bleeding episodes. In clinical trials, Qfitlia showed a 90% reduction in annualized bleeding rates compared to traditional on-demand treatments, highlighting its effectiveness in preventing spontaneous and injury-related bleeding.

Set for U.S. launch in April, Qfitlia will carry an annual list price of $642,000 for most patients, according to Brian Foard, Sanofi’s head of specialty care. U.S.-listed shares of Sanofi rose 1.7% following the approval announcement.

With approximately 33,000 males in the United States living with hemophilia, according to the CDC, Qfitlia provides a much-needed quality-of-life improvement. Unlike traditional factor replacement therapies, or newer gene therapies like CSL’s Hemgenix and BioMarin’s Roctavian, Qfitlia introduces a convenient and effective middle ground.

Experts like Margaret Ragni, professor at the University of Pittsburgh, emphasize the benefit: “Taking a drug every other month is a remarkable simplification for patients.”

As the hemophilia treatment landscape evolves, Sanofi’s Qfitlia could mark a new standard in care by balancing convenience, innovation, and efficacy for patients with this rare and chronic blood disorder.