Avacincaptad pegol new drug application receives priority review
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The FDA granted priority review for a new drug application for avacincaptad pegol for the treatment of geographic atrophy secondary to age-related macular degeneration, according to an Iveric Bio press release.
The submission was supported by positive 12-month efficacy and safety results from the phase 3 GATHER1 and GATHER2 pivotal clinical trials, in which avacincaptad pegol demonstrated observed efficacy rates of up to 35% for the treatment of geographic atrophy (GA).
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The FDA has set a Prescription Drug User Fee Act goal date of Aug. 19. No potential review issues have been identified, and the FDA is not planning to hold an advisory committee meeting for the complement C5 inhibitor.
Avacincaptad pegol is the only investigational therapy to receive breakthrough therapy designation for the treatment of GA secondary to AMD, the release said.
“We continue to accelerate our commercial launch plans and prepare for a potential approval of [avacincaptad pegol] for the treatment of GA throughout the AMD disease continuum,” Pravin U. Dugel, MD, president of Iveric Bio, said in the release. “This is important because AMD leads to irreversible, and in many cases catastrophic, vision loss.”
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