Sanofi Receives FDA Fast Track Designation for SAR446597 to Treat Geographic Atrophy in Age-related Macular Degeneration

Sanofi's SAR446597 has received "fast track" designation from the US FDA for the treatment of geographic atrophy due to age-related macular degeneration (AMD). The therapy uses a single intravitreal administration to inhibit two key pathways in the complement cascade. Geographic atrophy is a severe form of AMD that can cause permanent vision loss, affecting over 1 million people in the US, 2.5 million in Europe, and 5 million globally. Sanofi plans to launch a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.