Research & Development
Sobi files rolling BLA for gout drug SEL-212 with FDA
2 July 2024 -

Biopharmaceutical company Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI) said on Tuesday that it has submitted a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212, a potential treatment for chronic refractory gout.

This follows positive results from the DISSOLVE I and II trials and the FDA's Fast Track designation for SEL-212, highlighting the unmet need for new gout therapies.

Sobi in-licensed SEL-212 from Cartesian Therapeutics in June 2020 and is responsible for development and commercialisation outside of China.