Biopharmaceutical company Apellis said there was “no indication that drug product or manufacturing issues” contributed to reported events of retinal vasculitis in United States patients treated with Syfovre (pegcetacoplan injection).
Syfovre is a first-in-class treatment, approved earlier this year by the US Food and Drug Administration (FDA) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is not yet approved for use in Australia or New Zealand.
In a media release,1 Apellis said it had confirmed seven events of non-occulsive / occlusive retinal vasculitis.
“The safety of patients has always been – and continues to be – our top priority at Apellis,” said Dr Cedric Francois, Co-founder and Chief Executive Officer of Apellis.
we have seen no indication that drug product or manufacturing issues contributed to these events
“Following 68,000 commercial vials distributed and 23,000 clinical trial injections to date, these events continue to be very rare. Additionally, as part of our ongoing review, we have seen no indication that drug product or manufacturing issues contributed to these events.”
Meantime, further clinical data reported to the American Society of Retina Specialists Annual Scientific Meeting in the United States has reinforced the long-term safety and efficacy of Syfovre.2
“These positive long-term results deepen our understanding of Syfovre as a meaningful therapy for this progressive and irreversible disease, adding to the most robust dataset ever collected in GA,” said presenting author Dr Nathan Steinle. “It is very encouraging to see that Syfovre continues to work better and better the longer a patient is on treatment.”
References
- Apellis, Apellis provides update on review of rare safety events with Syfovre (pegcetacoplan injection) for geographic atrophy (news release, 29 July 2023) available at investors.apellis.com/news-releases/news-release-details/apellis-provides-update-review-rare-safety-events-syfovrer [accessed 1 Aug 2023].
- Apellis, Syfovre (pegcetacoplan injection) continued to demonstrate increasing treatment effects over 30 months in patients with geographic atrophy (GA) (news release, 30 July 2023) available at investors.apellis.com/news-releases/news-release-details/syfovrer-pegcetacoplan-injection-continued-demonstrate [accessed 1 Aug 2023].
