Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy
Shots:
- Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD
- Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD
- Data from both trials showed reduced GA lesion growth rate & sustained ACP efficacy, with restricted lesion growth observed over 2yrs follow-up in both studies
Ref: Astellas | Image: Astellas
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