PARIS (dpa-AFX) - Sanofi S.A. (SNYNF,SNY) said that the U.S. Food and Drug Administration 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 or 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.
Sanofi said it 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, for the treatment of patients with neovascular wet age-related macular degeneration.
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