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.
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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.