Shots:

• The approval is based on the P-III head-to-head (PEGASUS) study to evaluate the efficacy and safety of Aspaveli vs eculizumab in adults with PNH who had persistent anemia despite treatment with eculizumab for 3mos. The results showed an improvement in Hb levels
• The companies got the co-development rights for systemic pegcetacoplan. Sobi has exclusive Ex-US commercialization rights while Apellis has exclusive US commercialization rights for systemic pegcetacoplan and retains global commercial rights for ophthalmological pegcetacoplan & GA
• Aspaveli is the 1st targeted C3 therapy in the EU & is designed to regulate excessive activation of the complement cascade, body’s immune system

Ref: Almirall | Image: Apellis