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June 29, 2026

FDA issues complete response letter to Sobi’s NASP for gout

Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.

FDA issues complete response letter to Sobi’s NASP for gout