Promising Combination Treatment for Gout

Adverse effects included mild to moderate stomatitis and infusion reactions, with some serious adverse reactions. Adverse reactions occurred in 3.4% of the low-dose NASP group and 9.2% of patients in the high-dose NASP group compared with no placebo-treated patients.

The FDA has set a Prescription Drug User Fee Act, or target action date of June 27, 2026. In the meantime, we wait and see if the combination therapy receives FDA approval.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

Ursani M. Patient blog: Understanding gout symptoms and treatment. American College of Rheumatology. 2023 Apr 27.
FDA accepts biologics license application for Sobi’s NASP for patients with uncontrolled gout [news release]. Sobi. 2025 Sep 10.
A study of SEL-212 in patients with gout refractory to conventional therapy (DISSOLVE I) [NCT04513366]. ClinicalTrials.gov. 2025 Sep 11.
A study of SEL-212 in patients with gout refractory to conventional therapy II (DISSOLVE II) [NCT04596540]. 2024 Feb 20.
Phase 3 DISSOLVE program of SEL-212 in chronic refractory gout meets primary endpoint [news release]. Sobi. 2023 Mar 21.

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References

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References

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