• Organizations: Astellas
FDA approves updated label for IZERVAY to treat GA
Products

FDA approves updated label for IZERVAY to treat GA

Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.
FDA accepts revised sNDA of IZERVAY for GA
Products

FDA accepts revised sNDA of IZERVAY for GA

Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.
FDA issues company response letter to Astellas for IZERVAY supplemental NDA
Products

FDA issues company response letter to Astellas for IZERVAY supplemental NDA

Agency rejects proposal for positive 24-month data to be included in prescribing information; clarifies no issue with safety and benefit/risk of use.
Astellas receives permanent J-code for IZERVAY
Products

Astellas receives permanent J-code for IZERVAY

FDA-approved therapy is the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.