Apellis Says Mixed Phase III Results Position Geographic Atrophy Candidate For Filing

 
• By Joseph Haas
  
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Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.

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Apellis hopes to get the first approval for a geographic atrophy drug

Apellis Pharmaceuticals, Inc. plans to submit a new drug application for targeted C3 inhibitor pegcetacoplan in geographic atrophy (GA) based on the results of two Phase III studies, despite one of them failing to achieve its primary endpoint. The biotech said on 9 September that it thinks the data from both trials plus a successful Phase II study form a strong rationale for approval in an unmet medical need, while a majority of analysts commenting on the top-line data readout concurred with Apellis’s view.

GA is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness, estimated to affect 1...

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