FDA green light for first GA therapy, Apellis' Syfovre

18 February 2023

The US Food and Drug Administration (FDA) on Friday approved retinal disease specialist Apellis Pharmaceuticals' (Nasdaq: APLS) drug for geographic atrophy secondary to age-related macular degeneration (AMD) after pushing back its planned decision by three months to review more data.

Under the trade name Syfovre, pegcetacoplan injection becomes the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the USA and five million people worldwide.

Apellis shares closed up almost 7%, and rose a further 9.3% to $60.67 in after-hours trading.

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