Wider label approved for Izervay by FDA

The US Food and Drug Administration (FDA) approved expanding the prescribing information for Japanese drugmaker Astellas Pharma’s (TYO: 4503) Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

As a result, Izervay is now approved without a limitation on duration of dosing - providing physicians and patients with greater flexibility when managing GA, said Astellas, whose shares were lifted more than 3% to 1,494 yen by the news this morning.

The approval follows Astellas’ resubmission of the supplemental New Drug Application (sNDA) for Izervay on December 26, 2024, within days of meeting with the FDA to clarify the Agency’s feedback provided in the complete response letter (CRL) issued in November 2024. Izervay was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.