Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

Sanofi

16 July 2025 -  The US FDA has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy due to age-related macular degeneration.

SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and inhibit two critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway.

Read Sanofi press release 

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track