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news.Annexon has announced that the European Medicines Agency (EMA) has selected vonaprument for the Product Development Coordinator (PDC) pilot.
GA affects approximately one million people in the US and eight million globally. Credit: alpay tonga on Unsplash
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Vonaprument, formerly known as ANX007, is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation.
It has secured Priority Medicine (PRIME) designation in Europe and Fast Track Designation from the US Food and Drug Administration (FDA).
The PDC pilot, launched by the EMA in July 2025, aims to strengthen development support activities.
The PDC assists PRIME designation holders in navigating regulatory interactions, including expedited scientific advice, marketing authorisation application (MAA) submission readiness, and ad-hoc queries throughout the development programme.
Annexon senior vice president of regulatory, quality and clinical safety AJ Acker said: “We are honoured that vonaprument has been selected by the EMA to participate in the PDC pilot. This selection reflects the EMA’s commitment to fostering development support of vonaprument through faster, more flexible and expert-driven mechanisms.
“We value this opportunity to partner with the EMA in real time to help shape a strong and comprehensive submission. As a potential first-ever treatment for dry AMD with GA in Europe, we look forward to advancing vonaprument through this pilot toward registration.”
Vonaprument is currently being evaluated in ARCHER II, a global, randomised, double-masked, sham-controlled pivotal Phase III trial.
This trial has enrolled over 630 patients with advanced dry age-related macular degeneration (AMD)/geographic atrophy (GA). It aims to assess both visual acuity and structural measures to meet the global registration path in the US and Europe.
Enrollment for ARCHER II was completed in July 2025, and topline pivotal data is expected in the second half of 2026.
Dry AMD is the most common form of AMD, with GA being an advanced form of the disease. GA affects approximately one million people in the US and eight million globally.
Annexon’s pipeline spans three therapeutic areas: autoimmune, neurodegenerative, and ophthalmic diseases.
