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FDA grants fast track designation to Sanofi’s SAR446597 SAR446597, a gene therapy for GA, targets complement pathway components, reducing treatment burden by eliminating frequent injections Sanofi plans a phase 1 2 clinical study to evaluate SAR446597's safety, tolerability, and efficacy GA, an advanced form of AMD, affects millions globally, causing
Sanofi’s SAR446597 earns fast track designation in the US for . . . 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)
Sanofis SAR446597 Fast Track: A Breakthrough for Geographic Atrophy . . . Sanofi's SAR446597 aims to address this gap through a first-in-class mechanism The one-time intravitreal gene therapy delivers genetic material encoding two therapeutic antibody fragments targeting C1s (in the classical complement pathway) and factor Bb (in the alternative pathway)
FDA fast-tracks Sanofis gene therapy for eye disease GA The SAR446597 gene therapy could provide a one-off treatment for GA, a major cause of irreversible sight loss that affects millions of people around the world, and free patients from the need for