Apellis: No drug product, manufacturing issues contributed to Syfovre inflammation reports
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SEATTLE — Apellis Pharmaceuticals reported there is no indication that drug product or manufacturing issues contributed to recent reports of retinal vasculitis linked with Syfovre.
“Following 68,000 commercial vials distributed and 23,000 clinical trial injections to date, these events continue to be very rare,” Cedric Francois, MD, PhD, co-founder and CEO of Apellis, said in a press release. “Additionally, as part of our ongoing review, we have seen no indication that drug product or manufacturing issues contributed to these events.”
Apellis has received seven reports of retinal vasculitis since the launch of Syfovre (pegcetacoplan injection) and is evaluating one additional reported event. Since these cases have been reported, the company has reviewed the Syfovre manufacturing process and drug product as well as safety data from the phase 3 OAKS and DERBY clinical trials of Syfovre.
Apellis found no manufacturing-related issues impacting product quality, no quality issues or contaminants, and no evidence of drug-related immunogenicity in the clinical trial data. In addition, no single manufacturing lot was implicated. There were no events of retinal vasculitis reported by investigators or identified by an independent reading center in the clinical trials.
The phase 3 GALE extension study is currently evaluating the long-term efficacy and safety of Syfovre in patients with geographic atrophy secondary to age-related macular degeneration.
“We have over 15,000 injections now in this GALE data that I am going to present here at ASRS, and we have seen safety that is on par with what we saw in OAKS and DERBY,” Nathan C. Steinle, MD, said in this Healio Video Perspective from the American Society of Retina Specialists meeting.
Reference:
- Steinle NC. Long-term efficacy of pegcetacoplan in patients with geographic atrophy. Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
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