EMA accepts marketing authorization application for avacincaptad pegol
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Key takeaways:
- The European Medicines Agency accepted the marketing authorization application for avacincaptad pegol.
- Next, the Committee for Medicinal Products for Human Use will review the application.
The European Medicines Agency accepted the marketing authorization application for avacincaptad pegol, according to a press release from Astellas Pharma.
Avacincaptad pegol is a complement C5 inhibitor under investigation in the EU for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.
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The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the application under the centralized licensing procedure for the 27 member states of the European Union.
“This acceptance of our EU marketing authorization application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide,” Pravin U. Dugel, MD, president of Iveric Bio, an Astellas company, said in the release. “We look forward to collaborating with CHMP throughout the review process and hope to make [avacincaptad pegol] available for patients in Europe.”
The application is based on the GATHER1 and GATHER2 phase 3 clinical trials that assessed the safety and efficacy of monthly 2 mg intravitreal avacincaptad pegol in patients with GA secondary to AMD. Participants who received avacincaptad pegol demonstrated a statistically significant reduction in the rate of GA growth compared with those who received sham.
The FDA approved avacincaptad pegol intravitreal solution as Izervay in the U.S. earlier this month.
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