MedPath

Avacincaptad pegol

Generic Name
Avacincaptad pegol
Brand Names
Izervay
Drug Type
Biotech
Chemical Formula
-
CAS Number
1613641-69-2
Unique Ingredient Identifier
TT0V5JLG5B
Background

Avacincaptad pegol is an RNA aptamer covalently bound to a branched polyethylene glycol (PEG) molecule. It was developed to treat an advanced form of age-related macular degeneration (AMD) called geographic atrophy (GA). AMD is the leading cause of vision loss in developed countries for people over 50 years old, with a global estimate of 170 million individuals affected. AMD eventually progresses to bilateral and irreversible loss of vision, whether or not the patients have the non-neovascular (dry) or the neovascular (wet) form of AMD. Although anti-VEGF therapy is available for the neovascular form of AMD, no treatment was approved for GA.

Avacincaptag pegol was approved by the FDA on August 4, 2023, under the brand name IZERVAY for the treatment of GA secondary to AMD. This approval is based on the positive results obtained from 2 phase 3 clinical trials GATHER1 and GATHER2.

Indication

Avacincaptad pegol is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Associated Conditions
Dry Macular Degeneration
Associated Therapies
-
globenewswire.com
·

Age-Related Macular Degeneration (AMD) Drugs Market Research 2024

The Age-Related Macular Degeneration (AMD) Drugs Market is projected to reach USD 17.37 Billion by 2029, growing from USD 10.46 Billion in 2024 at a CAGR of 10.7%. Factors driving growth include an aging population, lifestyle factors, and rising incidences of AMD. Vabysmo is expected to show the highest growth due to positive feedback and efficacy. Hospitals will witness high growth as end users. Biologics will dominate the approval type segment. North America is the fastest-growing region. Key companies profiled include Regeneron Pharmaceuticals, Bayer AG, F. Hoffmann-La Roche Ltd, and Novartis AG.
rttnews.com
·

Biotech Stocks Facing FDA Decision In November 2024

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah. November awaits decisions on Journey Medical's DFD-29, Merus' Zenocutuzumab, Astellas' IZERVAY, PTC Therapeutics' Upstaza, Autolus' Obe-cel, Applied Therapeutics' Govorestat, BridgeBio's Acoramidis, and Jazz Pharmaceuticals' Zanidatamab.

Astellas Withdraws Izervay's European Approval Filing

Astellas withdraws Izervay's European approval filing, contrasting with its US success, and considers future actions for European market.
pharmaphorum.com
·

Astellas pulls geographic atrophy drug filing in the EU

Astellas withdraws EMA filing for avacincaptad pegol, a GA treatment, following EU regulator feedback. Despite US FDA approval as Izervay, no EU treatments exist for GA associated with AMD. Astellas remains committed to bringing the drug to market in Europe.

Astellas withdraws Europe ACP application for AMD treatment

Astellas Pharma withdraws its marketing authorisation application for avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from the European Medicines Agency (EMA) following discussions with the CHMP. ACP, an investigational synthetic aptamer, inhibits the complement C5 protein, which contributes to GA-related vision loss. Astellas remains confident in ACP's clinical profile and its potential to benefit GA patients, despite the withdrawal, and is committed to exploring all options to make ACP accessible globally.

Astellas Pharma Withdraws EU Application for Key Drug

Astellas Pharma withdrew its marketing application for avacincaptad pegol from the EMA due to interactions, despite positive U.S. results. The company remains optimistic about the drug's clinical benefits.
healio.com
·

VIDEO: US specialist sympathizes with EU colleagues over EMA rejection of pegcetacoplan

US specialist Baruch D. Kuppermann sympathizes with EU colleagues over EMA's rejection of pegcetacoplan, noting the disappointment in limited treatment options for geographic atrophy patients.
© Copyright 2025. All Rights Reserved by MedPath