FDA Fast Tracks One-Time Intravitreal Gene Therapy for Geographic Atrophy

FDA fast tracks one-time intravitreal gene therapy for geographic atrophy

 The FDA granted fast track designation to SAR446597, an intravitreal gene therapy for the treatment of geographic atrophy due to age-related macular degeneration, according to a press release from Sanofi.

FDA fast-tracks Sanofi's gene therapy for eye disease GA

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy, a major cause of blindness

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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…