Trial Profile

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 02 Jul 2026

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At a glance

26 Jun 2026 According to a Swedish Orphan Biovitrum media release, the Company received a Complete Response Letter from the U.S. FDA for the Company's Biologics License Application the FDA required that the Company provide additional data mainly related to manufacturing control strategy of the biological component of NASP and to address contract manufacturing facility deficiencies. The FDA identified no concerns regarding the clinical efficacy or safety of NASP that impact approvability.
25 Oct 2025 According to Sobi North America media release, data from this trial presented at the annual American College of Rheumatology (ACR) Convergence 2025 meeting
25 Oct 2025 Results published in the Sobi North America Media Release

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