In what seems to be the latest Syfovre safety update, in early October 2023 Apellis reported an increase in the number of Syfovre retinal vasculitis cases, but Apellis did not provide any significant new information regarding an “explanation” as to how these Syfovre adverse reaction events happened.
EndPoints News Senior Editor Amber Tong, in her August 23, 2023 article “Apellis’ safety probe into eye drug unearths issues with injection kits, while side effects remain ‘very rare'”, summarized the earlier August 2023 Apellis Syfovre safety update as follows:
Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.
Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial….
The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.
On October 5, 2023, Apellis Pharmaceuticals issued an update for its Syfovre investigation into retinal vasculitis cases involving patients who used Syfovre for geographic atrophy (GA). From one part of this company press release, “Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023”, we get the latest number of Syfovre-associated retinal vasculitis cases:
- In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
- Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.
In summary, there is an increase in the number of Syfovre retinal vasculitis cases, but we do not have any further “explanation” about how or why these Syfovre retinal vasculitis adverse reaction events happened.[Read article in full at original source]
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