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17 Jul 2025
Admin
News Article

US FDA grants fast track designation to Sanofi’s SAR446597 for age-related macular degeneration

Overview

The US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The fast track designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses.

SAR446597: Dual-Target Gene Therapy for Sustained Complement Inhibition in Retinal Disease

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.
This dual-targeting approach potentially offers clinical advantages by providing sustained complement suppression within the retinal microenvironment while significantly reducing treatment burden through elimination of frequent intravitreal injections.
The therapy aims to address the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins following a single intervention.

Beginning of phase 1/2 study- Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.

Current evaluation of SAR402663

Sanofi is also currently evaluating SAR402663, a one-time intravitreal gene therapy, in a phase 1/2 study (clinical study identifier: NCT06660667), for the treatment of patients with neovascular wet age-related macular degeneration.

About age-related macular degeneration (AMD)

AMD is an acquired progressive degeneration of the retina that affects approximately 200 million people globally. Geographic atrophy is an advanced form of dry AMD.
It is characterized by enlarging irreversible atrophic lesions due to degeneration of retinal cells leading to permanent vision loss in many patients.
GA affects approximately 1 million people in the US, more than 2.5 million in Europe, and over 5 million people worldwide and has a profound impact on quality of life, including ability to read, drive and perform other daily activities.

Sanofi’s mission for serious neuroinflammatory and neurodegenerative diseases

Our goal is to improve the lives of people with serious neuroinflammatory and neurodegenerative diseases.
We are testing the bounds of clinical possibility to research therapies that may address multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy (CIDP), Alzheimer’s disease (AD), Parkinson’s disease (PD), age-related macular degeneration (AMD) and other neurological diseases for the people who need them most.
Emerging scientific innovations and investments in ophthalmology have the potential to drive a new phase of growth for Sanofi.

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