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Apellis Aims New Pegcetacoplan Data At Market, Not Regulators

 
• By Alaric DeArment

The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.

Apellis said it was submitting new, longer-term follow-up data to the FDA for its geographic atrophy drug • Source: Shutterstock

Apellis Pharmaceuticals, Inc. is looking at a three-month extension of the US Food and Drug Administration action date for its pegcetacoplan in geographic atrophy (GA), but that’s because it is choosing to submit additional data to the agency. The firm opted for the short delay in order to have a more compelling dataset to take to the market.

Apellis said 3 November that it would submit 24-month Phase III data from the 637-patient DERBY and 621-patient OAKS clinical...

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