Apellis Has New Hope for Pegcetacoplan With Longer-Term Data
18-Month Results Could Vindicate Geographic Atrophy Program
One of two Phase III trials for pegcetacoplan in geographic atrophy previously failed, but 18-month data showed statistically significant and possibly accelerating improvement.
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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.
November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.
The company plans to file the complement C5 inhibitor with the US FDA, but Apellis already has a drug pending for the indication.