CHMP to review MAA for geographic atrophy treatment
Posted: 18 August 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Iveric Bio’s marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA).
“This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. We look forward to collaborating with Committee for Medicinal Products for Human Use (CHMP) throughout the review process and hope to make ACP available for patients in Europe,” commented Dr Pravin Dugel, President of Iveric Bio, an Astellas company.
EMA’s CHMP will begin its review of the MAA under the centralised licensing procedure for all 27 member states of the EU.
Clinical evidence that supported the marketing authorisation application
The MAA is based on the GATHER1 and GATHER2 Phase III clinical trials.
For a monthly 2mg intravitreal dose of ACP, primary analysis showed that over 12 months, the treatment provided a statistically significant reduction in the rate of GA growth in patients treated with ACP compared to a sham treatment.
ACP was approved by the US Food and Drug Administration (FDA) as IZERVAY™ (avacincaptad pegol intravitreal solution) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on 4 August 2023.
Avacincaptad Pegol
Avacincaptad pegol (ACP) is a complement C5 protein inhibitor. An overactive complement system and the C5 protein are thought be key in development and growth of scarring and vision loss associated with GA secondary to AMD. By targeting this protein, ACP has potential to reduce activity of the complement system that causes the degeneration of retinal cells. This could therefore potentially slow the progression of GA.
News of the EMA’s decision about the MAA is welcome as it is estimated that globally, approximately five million people have GA in at least in one eye, according to a 2017 paper published in Retina.
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Big Pharma, Biopharmaceuticals, Clinical Development, Clinical Trials, Drug Development, Industry Insight, Regulation & Legislation, Research & Development (R&D), Therapeutics
Related organisations
Astellas Pharma, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), Iveric Bio, US Food and Drug Administration (FDA)
