Astellas receives Complete Response Letter for Izervay, Apellis rallies

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug application for Izervay for the treatment of geographic atrophy secondary to age-related macular degeneration. The drug application sought to include positive two-year data in the U.S. Prescribing Information for Izervay based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through year two. The FDA stated the agency cannot approve the application in its present form by the action date of November 19. “The FDA comments outlined in the CRL are unrelated to the safety and benefit/risk of the use of IZERVAY; rather, the comments focus on a statistical matter related to labelling language proposed by Astellas. Astellas is seeking further clarification from the FDA and looks forward to working with the agency to quickly address the agency’s feedback,” the company said in a statement. Shares of Apellis (APLS), whose Syfovre competes with Izervay, are up 3% to $26.99 in premarket trading.