The US FDA has approved Selarsdi (ustekinumab-aekn) injection (SC) for adults & pediatric patients (≥6yrs.) with moderate to severe plaque Pso & active PsA. Teva will commercialize it in the US as per an agreement b/w Teva & Alvotech
The approval was based on 2 studies incl. AVT04-GL-301 trial assessing the efficacy, safety & immunogenicity of Selarsdi vs Stelara in moderate to severe chronic plaque Pso patients (n=581) & P-I (AVT04-GL-101) trial assessing the PK, safety, tolerability & immunogenicity of Selarsdi (45mg/0.5mL, SC) vs Stelara in healthy adults (n=294)
Both companies have entered into a settlement & license agreement with J&J (Stelara’s manufacturer) to market Selarsdi across the US in Feb 2025
Ref: Teva | Image: Teva
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