The U.S. Food and Drug Administration (FDA) approved a supplemental application for Praluent (alirocumab) on October 9, 2025. This approval, designated BLA 125559 S-47, pertains to an efficacy update for the drug and was sponsored by Regeneron Pharmaceuticals.
What this means
This supplemental approval for Praluent (alirocumab) signifies an update or expansion related to the drug's demonstrated efficacy. Supplemental applications for efficacy typically involve new data supporting an existing indication, a new patient population, or an enhanced understanding of the drug's effectiveness. This update, sponsored by Regeneron Pharmaceuticals, reinforces the therapeutic profile of Praluent.
Source
The information regarding this supplemental application approval for Praluent (alirocumab) was obtained from the U.S. Food and Drug Administration (FDA) on October 9, 2025. The details are publicly accessible on accessdata.fda.gov, specifically under supplemental application BLA 125559 S-47.