Astellas Pharma Inc. has announced it is withdrawing its marketing authorisation application for avacincaptad pegol (ACP) intravitreal solution from the European Medicines Agency (EMA).1
The company’s decision to withdraw its application followed interactions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Astellas maintains that the clinically meaningful benefit of ACP in slowing geographic atrophy (GA) lesion growth outweighs the risks. And it said it remains confident in ACP’s clinical profile.
In August 2023, Iveric Bio received United States Food and Drug Administration (FDA) approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of GA secondary to age-related macular degeneration (AMD). It was the second GA treatment approved by the FDA.
Japan-based Astellas Pharma acquired Iveric Bio in May 2023 for US$5.9 billion.
Astellas maintains that the clinically meaningful benefit of ACP in slowing geographic atrophy (GA) lesion growth outweighs the risks.
Astellas spokesperson Marci English said the company “would like to emphasise our confidence in ACP’s clinical profile as demonstrated in two randomised sham-controlled trials and its potential to benefit people living with geographic atrophy”.
“GA is a devastating progressive disease, which leads to severe and irreversible visual impairment and blindness. As the science and understanding of GA expands, Astellas and other companies are pioneering the way to bring new treatment options…
“While we are disappointed with the CHMP’s response, we have seen the impact this medicine has had for GA patients in the US and remain committed to serving unmet patient needs globally.”
Astellas is reviewing the potential financial impact of the European withdrawal.
Reference
- Astellas provides update on marketing authorization application for avacincaptad pegol (ACP) in the European Union (news release, 28 Oct 2024), available at: astellas.com/en/news/29531 [accessed 30 Oct 2024].
