Astellas pulls EU filing for avacincaptad pegol

28 October 2024

Japanese drugmaker Astellas Pharma (TYO: 4503) revealed it has decided to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP), an investigational synthetic aptamer that inhibits the complement C5 protein, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The company's decision to withdraw its application followed interactions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Astellas stressed its belief that the clinically meaningful benefit of ACP in slowing GA lesion growth outweighs the risks and remains confident in ACP’s clinical profile and believes its capacity to slow disease is a benefit for people living with GA.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight





More Features in Pharmaceutical