Iveric Bio’s Zimura (avacincaptad pegol) Receives the US FDA’s Breakthrough Therapy Designation for Geographic Atrophy
Shots:
- The US FDA has granted BTD to avacincaptad pegol (ACP) for GA secondary to AMD. The designation was based on the 12mos. primary efficacy EPs data from the (GATHER1 & 2) studies evaluated ACP (2mg, IV) in 286 & 448 patients
- The trials met its 1EPs i.e., the therapy showed a treatment effect with the first measurement @6mos. with efficacy rates of ~35% increased over time, treatment difference of 35% & 18% in both trials over sham using non-transformed data & 28% & 14% using square root transformation with no events of serious intraocular inflammation, vasculitis, or endophthalmitis
- The company submitted 1st part of its NDA for rolling review incl. clinical data from the (GATHER1 & 2) trials & is expected to submit the final part of the NDA at the end of 2022
Ref: Businesswire | Image: Iveric Bio
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
