FDA grants fast track designation to Sanofi’s SAR446597

The US Food and Drug Administration (FDA) recently granted fast track designation to Sanofi’s SAR446597 for the treatment of geographic atrophy (GA).¹

SAR446597 is a one-time intravitreal gene therapy treatment that “delivers genetic material encoding 2 therapeutic antibody fragments that target and inhibit 2 critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway,” a press release said.¹

Through the dual targeting approach of SAR446597, treatment burden is significantly reduced through the elimination of frequent intravitreal injections. SAR446597 “aims to address the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins following a single intervention,” a press release stated.¹

A phase 1/2 clinical study to evaluate the safety, tolerability, and efficacy of SAR446597 is in the plans for Sanofi. The company is currently evaluating SAR402663 in a phase 1/2 study (NCT06660667) for the treatment of neovascular wet age-related macular degeneration (nAMD). SAR402663 is also a one-time intravitreal gene therapy.¹

Affecting roughly 200 million people globally, AMD and GA are progressive retina degeneration diseases. GA is an advanced form of AMD, characterized by lesions caused by the degeneration of retinal cells. GA specifically affects approximately 1 million people in the US, more than 2.5 million in Europe, and more than 5 million people worldwide, causing permanent vision loss and impacting quality of life.¹

Reference:

1. Sanofi Winthrop Industrie. Press Release: Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration. GlobeNewswire News Room. Published July 16, 2025. Accessed July 17, 2025. https://www.globenewswire.com/news-release/2025/07/16/3116124/0/en/Press-Release-Sanofi-s-SAR446597-earns-fast-track-designation-in-the-US-for-geographic-atrophy-due-to-age-related-macular-degeneration.html