FDA Fast Tracks One-Time Intravitreal Gene Therapy for Geographic Atrophy
UNITED STATES, JUL 16 – Sanofi's SAR446597 gene therapy aims to reduce injection frequency by targeting two complement pathway components and received FDA fast track due to unmet needs in geographic atrophy treatment.
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8 Articles
Innovative Therapies Help Restore Vision Loss in Macular Degeneration
Age-related macular degeneration (AMD) remains a leading cause of vision loss, but new therapies are reshaping its treatment. Recently approved drugs, pegcetacoplan and avacincaptad pegol, target the complement system to slow dry AMD progression.


FDA grants fast track designation to Sanofi’s SAR446597
This expedited process is intended to hasten the development and review of new drugs that address serious conditions with unmet medical needs. The FDA established this procedure to The post FDA grants fast track designation to Sanofi’s SAR446597 appeared first on Pharmaceutical Business review.
Sanofi’s Intravitreal Gene Therapy Earns FDA Fast Track Designation for Geographic Atrophy
The 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. SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and in…
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