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 facilitate the earlier delivery of significant new medications to patients, encompassing a wide array of serious diseases.
SAR446597 works by delivering genetic material that encodes two antibody fragments targeting key components of the complement pathway. By inhibiting C1s in the classical pathway and factor Bb in the alternative pathway, this dual-targeting strategy offers sustained complement suppression within the retina.
Sanofi is preparing to initiate a Phase I/II study assessing SAR446597’s tolerability, safety and efficacy.
Additionally, the company is currently conducting research on another intravitreal gene therapy named SAR402663 in a Phase I/II trial aimed at treating patients with neovascular wet AMD.
AMD is a progressive retinal degeneration that affects an estimated 200 million individuals worldwide.
GA is an advanced stage of dry AMD, which is characterised by progressive growth of irreversible atrophic lesions resulting from the degeneration of retinal cells, which ultimately causes permanent vision loss.
Sanofi is an R&D-focused, AI-driven biopharmaceutical company and is researching therapies for conditions such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, and age-related macular degeneration.
With a focus on emerging scientific innovations, Sanofi is also exploring new treatments for retinal diseases linked to immune system disorders.