Apellis urges doctors to switch injection kits for Syfovre amid safety event update

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 biotech’s shares shot up 32% to $40.7 in after-hours trading — although that’s still less than half of its stock price in July before the safety scare triggered the big plunge.

The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.

Caroline Baumal

“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,” Apellis chief medical officer Caroline Baumal said in a statement.

Apellis also reported its latest tally of retinal vasculitis: There are now eight confirmed cases in total, meaning one additional case compared to its last update in late July. On top of that, the company said there are two events of suspected retinal vasculitis that have not been confirmed.

Cowen analyst Phil Nadeau remarked that as such, the rate of this side effect remains “encouragingly low” and the tally of eight cases matches what was previously reported by the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee.

Samimy added it increases “confidence that the RV cases are indeed rare (0.01%) and acceptable in light of almost certain progression to blindness in GA.” Retinal vasculitis is severe inflammation that can lead to significant vision loss.

Out of the eight patients who experienced retinal vasculitis, Apellis said two have severe vision impairment that is unlikely to be resolved. Two others have recovered vision nearly back to baseline, one remained stable at baseline vision and outcomes for the last three are still pending.

In the same update, Apellis said 26,000 vials of Syfovre have been distributed in the third quarter, bringing the number of vials sold since launch to 78,000 and the total to more than 100,000 if you consider those distributed during clinical trials. Those numbers, Samimy wrote, bucks “the general consensus that Syfovre sales would come to a screeching halt.”

Doctors and analysts will now be watching for the next update on safety events while Apellis prepares to face off against a new competitor in Iveric Bio’s Izervay following its recent approval.

While both drugs target the complement pathway, Syfovre blocks the C3 cyclic peptide, while Izervay is a C5 inhibitor.

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