Sobis giktansökan accepterad av FDA

Sobis ansökan om marknadsgodkännande för sin nya giktbehandling har tagits emot och accepterats av den amerikanska läkemedelsmyndigheten FDA, och ett beslut väntas nästa sommar.

By Anders Göransson

September 10, 2025 2:09 PM

Ansökan gäller den nya infusionsbehandlingen NASP (Nanoencapsulated Sirolimus plus Pegadricase), tidigare benämnd SEL-212, som utvecklas som behandling av okontrollerad gikt.

Patienter som lider okontrollerad gickt har kronisk inflammation som ger akuta giktattacker och ansamlingar av urinsyra, vilket leder till tofi, smärtsamma knölar av urinsyrakristaller under huden.

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