Posted by Michael Wonder on 08 Feb 2024
Eplontersen granted US FDA fast track designation for patients with transthyretin-mediated amyloid cardiomyopathy
8 February 2024 - Ionis Pharmaceuticals announced today that the US FDA has granted fast track designation to Ionis and AstraZeneca's eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults.
The global CARDIO-TTRansform Phase 3 study of eplontersen in adults with ATTR-CM is fully enrolled with more than 1,400 patients – making it the largest study in this patient population to date.
