Amerikanskt bakslag för Astra Zenecas lupusbehandling

I EU har Astra Zenecas nya beredningsform av lupusläkemedlet Saphnelo redan godkänts. I USA blir det däremot ett nej – åtminstone tills vidare.

By Lotta Naesenius

February 3, 2026 9:55 AM

Amerikanska läkemedelsmyndigheten FDA godkänner inte i nuläget den subkutana formen av Saphnelo (anifrolumab), som ges till vuxna med den autoimmuna sjukdomen systemisk lupus erythematosus (SLE).

Ansökan baserades på en fas III-studie som uppnådde sitt primära effektmått, men FDA utfärdade ett så kallat Complete Response Letter (CRL) och efterfrågade kompletterande information.

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