FDA nod for Izervay, a new treatment for geographic atrophy
The US Food and Drug Administration (FDA) approved Japanese drug major Astellas Pharma’s (TYO: 4503) Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) late Friday, sending the firm’s shares up more than 10% to 2,191 yen today.
Izervay, a new complement C5 inhibitor, is the only approved GA treatment with a statistically-significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials, noted Astellas.
Astellas gained rights to the product through its recently completed buy of Iveric Bio for about $5.9 billon. Izervay is anticipated to be available in the USA in two-four weeks.
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