FDA accepts Iveric Bio's NDA, grants priority review for GA drug
On the heels of a second Phase III win in geographic atrophy last year, Iveric Bio is now waiting at the FDA’s doors for its final decision, which is set to come after competitor Apellis Pharmaceuticals hears from the regulator later this month.
The eye disease-focused biotech announced Thursday afternoon the FDA had accepted Iveric’s NDA for avacincaptad pegol (ACP), a complement C5 protein inhibitor and the biotech’s lead candidate. The biotech is seeking FDA approval to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Geographic atrophy is a severe form of dry AMD.
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