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HomeminewsSyfovre Marketing Applications Validated

Syfovre Marketing Applications Validated

The availability in Australia of pegcetacoplan injection (Syfovre) – the first-in-class treatment for geographic atrophic age-related macular degeneration (AMD) – is a step closer, with manufacturer Apellis Pharmaceuticals announcing it has received validation of its marketing application.

The global biopharmaceutical has announced it has received validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland.

Decisions by local regulatory authorities in these countries are expected in the first half of 2024.

In what’s been described as “the most important event in retinal ophthalmology in more than a decade”, the United States Food and Drug Administration (FDA) approved Syfovre as the first and only treatment for geographic atrophy (GA) secondary to AMD in March.

We look forward to working with regulators in Canada, Australia, the United Kingdom, and Switzerland to deliver the first potential treatment for GA in these countries.

AMD is a leading cause of blindness and severe vision loss. Until now there has been no treatment for the ‘dry’ form of the disease.

“With our first approval of pegcetacoplan in the US and multiple global decisions to be expected within the next year, we are closer than ever to achieving our goal of bringing pegcetacoplan to patients worldwide,” said Dr Jeffrey Eisele, chief development officer at Apellis.

“We look forward to working with regulators in Canada, Australia, the United Kingdom, and Switzerland to deliver the first potential treatment for GA in these countries.”

A marketing authorisation application for pegcetacoplan is also under review by the European Medicines Agency with a decision expected in early 2024.

In a news release, Apellis said the marketing applications were validated via the Access Consortium Work-Sharing Initiative, which supports coordinated review across multiple health authorities. This initiative has the potential to offer an efficient regulatory pathway and lead to timely access to treatments for patients.

The approval of Syfovre in the US was based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients.1

Reference

  1. Apellis Pharmaceuticals, FDA Approves Syfovre (pegcetacoplan injection) as the First and Only Treatment for Geographic Atrophy (GA), a Leading Cause of Blindness (news release), 17 February 2023, available at investors.apellis.com/news-releases/news-release-details/fda-approves-syfovretm-pegcetacoplan-injection-first-and-only [accessed 28 Feb 2023].

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