Sanofi announced that the US Food and Drug Administration (FDA) has granted fast track designation to SAR402663, an investigational gene therapy for neovascular age-related macular degeneration (AMD). The therapy is designed as a one-time intravitreal injection, which could reduce the treatment burden for patients with this condition.
The FDA’s fast track program is intended to speed up the development and review of drugs for serious illnesses where there is an unmet medical need. This process helps bring important new medicines to patients sooner.
SAR402663 works by delivering genetic material encoding soluble FLT01, which is designed to inhibit vascular endothelial growth factor (VEGF). Sanofi is currently conducting a phase 1/2 clinical study (NCT06660667) in patients with neovascular AMD. The goal of this gene therapy is to address disease pathology by inhibiting abnormal blood vessel growth, reducing vascular leakage, and minimizing retina damage. It may also lessen the need for frequent injections.
Neovascular or “wet” AMD affects more than one million people in the United States and six million globally. This severe form of macular degeneration can cause significant vision loss and impact daily activities such as reading and driving. Globally, AMD affects around 200 million people.
Sanofi stated its broader focus on neurology includes research into therapies for multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, AMD, and other neurological diseases. The company sees emerging innovation in ophthalmology as a potential driver of future growth.
According to Sanofi: “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), AMD and other neurological diseases for the people who need them most. Emerging scientific innovation and investment 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 describes itself as an R&D-driven biopharma company focused on developing medicines and vaccines based on its understanding of the immune system: “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.”
The company cautioned that forward-looking statements included in its communications are subject to risks related to research outcomes, regulatory decisions, market conditions, intellectual property matters, exchange rates, global crises affecting business partners or employees, among others.
Sanofi shares are listed on EURONEXT under SAN and NASDAQ under SNY.
