FDA Reviews Astellas’ Revised Izervay sNDA
Astellas Pharma said that the FDA has accepted for review a revised application for its complement C5 inhibitor Izervay (avacincaptad pegol) that aims to add positive two-year clinical trial data to the drug’s label.
The revised supplemental new drug application, accepted on January 6, seeks a label update regarding the dosing period and interval of Izervay for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) based on data from the GATHER2 Phase III trial. The FDA’s target action date was set to February 26.The latest filing comes after the Japanese pharma received a complete response letter from the agency last November, which pointed out statistical matters related to the proposed label update, and not the safety or benefit/risk profile of the drug itself. The company made the re-submission following its meeting with the FDA in December.
The drug’s label currently recommends an intravitreal injection to each affected eye once monthly for up to 12 months. The GATHER2 PIII trial gauged the efficacy and safety of monthly and every-other-month dosing through Year 2.
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