Iveric Bio Reports EMA Acceptance of MAA for Avacincaptad Pegol to Treat Geographic Atrophy
Shots:
- The EMA has accepted the MAA for regulatory review of avacincaptad pegol, a complement C5 inhibitor for the treatment of GA secondary to AMD. The MAA was based on the results from the P-III (GATHER1 & 2) trials evaluating safety and efficacy of ACP (qm, 2mg, IVT) in 286 & 448 patients
- The primary analysis showed a significant reduction in the rate of GA growth in patients treated with ACP over sham in each registrational trial over a 12mos. period while safety was evaluated in ~700 patients across both trials
- Avacincaptad pegol, a complement C5 protein inhibitor was approved in the US as Izervay for the treatment of GA secondary to AMD
Ref: PR Newswire | Image: Iveric Bio
Rewlated News:- Iveric Bio's Izervay (avacincaptad pegol intravitreal solution) Receives the US FDA’s Approval for the Treatment of Geographic Atrophy
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