Apellis Pharmaceuticals has advised medical practitioners to discontinue the usage of 19-gauge filter needle kits to draw out its geographic atrophy drug Syfovre (pegcetacoplan injection) from the vial.
In February, the US Food and Drug Administration (FDA) approved Syfovre for treating geographic atrophy, expanding its use beyond paroxysmal nocturnal haemoglobinuria (PNH). Syfovre is forecasted to be Apellis’ blockbuster drug, with GlobalData estimating sales of up to $2.8bn in 2029.
GlobalData is the parent company of Pharmaceutical Technology.
The news did little to deter the growth of Apellis’s stock, with it being up over 28% pre-market on 23 August, compared to the market close on the previous day.
A total of eight retinal vasculitis, an inflammation of blood vessels in the retina of the eye, events have been reported since April 2023. Of these, five were occlusive while three were non-occlusive events.
Although Apellis noted that no causal relationship between the kits in question and the incidence of retinal vasculitis has not yet been established, it was quick to recommend the use of kits with 18-gauge filter needles over the 19-gauge needles. Moreover, the company has stopped the distribution of injection kits with the 19-gauge filter needle.
In the press release, Apellis chief medical officer Caroline Baumal said: “Based on the findings from our investigation, we believe it is prudent that practitioners only use the kits with the 18-gauge filter needle, which are already in distribution.
“This recommendation is out of an abundance of caution as patient safety is our top priority.”
The company also reported that there were internal structural variations in the 19-gauge and 1½in filter needle included as part of some kits, after conducting an internal investigation.
More than 100,000 Syfovre kits are currently in distribution, which either contain 18-gauge or 19-gauge filter needles, with 24,000 of these being used in clinical trials.