Astellas' (ALPMY.US) C5 complement inhibitor has been approved by the FDA.

On February 13, Astellas (ALPMY.US) announced that the FDA approved its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). With this approval, Izervay's dosing duration is no longer limited, providing greater flexibility for physicians and patients to manage GA. Astellas' sNDA application extended Izervay's dosing interval and reduced its dosing frequency based on the two-year results of the Phase III GATHER2 study. Izervay was approved by the FDA in August 2023 for the treatment of GA secondary to AMD, with a dosing regimen of once every month for up to one year. In the GATHER1 study, the average growth rate of GA lesions in patients treated with Izervay at 2mg and 4mg doses was reduced by 27.38% (p=0.0072) and 27.81% (p=0.0051), respectively, compared to the placebo group.