Astellas submits NDA for avacincaptad pegol in Japan

Japanese drugmaker Astellas Pharma (TYO: 4503) says it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for conditional approval of avacincaptad pegol intravitreal solution (ACP), a synthetic aptamer that inhibits the complement C5 protein, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

If approved, ACP has the potential to become the first and only GA treatment available in Japan, according to Astellas.

GA is a progressive form of AMD that can cause irreversible vision loss, with no treatments currently approved outside the USA or Australia. Globally, over five million people are estimated to have GA and, without timely treatment, an estimated 66% of people living with GA may become legally blind or severely visually impaired. As a result, GA secondary to AMD has a substantial impact on patients’ daily lives and psychological wellbeing.