Apellis Updates on Injection Kits and Rare Safety Events with SYFOVRE® (pegcetacoplan injection)

 

• Internal structural variations were identified in the 19-gauge filter needle included in certain injection kits; Apellis recommends use of kits with the 18-gauge filter needle, which are already in distribution
  

• More than 100,000 vials have been distributed/administered between real world and clinical trials; since last update, confirmed one additional event of retinal vasculitis that occurred in May
  

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) (“the Company”) today provided an update on injection kits supplied by Apellis and an update on the rare events of retinal vasculitis reported in real-world treatment with SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Recommended use of filter needles included in certain injection kits

As part of the comprehensive investigation into the real-world safety events, internal structural variations were identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits. Filter needles are used to withdraw treatment from the vial when preparing for an injection procedure. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.

The Company recommends that practitioners immediately discontinue use of any injection kits that contain the 19-gauge filter needle and use injection kits with the 18-gauge filter needle, which are already in distribution. While injection kits previously contained one of two types of filter needles (either 18- or 19-gauge), Apellis is now exclusively distributing injection kits with the 18-gauge filter needle.

“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,” said Caroline Baumal, M.D., chief medical officer of Apellis.

https://finance.yahoo.com/news/apellis-provides-updates-injection-kits-204300233.html