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Sanofi s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
Paris, July 16, 2025. 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.
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.
Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.
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.
age-related macular degeneration and geographic atrophy
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.
About Sanofi in neurology
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. We are exploring innovative
therapies in retinal diseases with unmet need especially where they connect with immune system conditions.
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people s lives and
delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our
team is guided by one purpose: we chase the miracles of science to improve people s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare,
environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Sandrine Guendoul | +33 6 25 09 14 25 |
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
L o Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 |
L a Ubaldi | +33 6 30 19 66 46 |
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Aliz Kaisserian | +33 6 47 04 12 11 |
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 |
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 |
Thibaud Ch telet | +33 6 80 80 89 90 |
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
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