FDA Rebuffs Sobi Gout Drug Over Manufacturing Concerns

The Swedish biopharmaceutical firm must now engage with federal regulators to determine a path forward for resubmission. The FDA’s feedback centered on the biological component’s control strategy and the operational standards of the third-party facilities involved in production. Despite the regulatory hurdle, the company maintains that the therapy addresses a critical gap for the roughly 200,000 Americans suffering from uncontrolled gout who do not respond to existing oral urate-lowering treatments.

Lydia Abad-Franch, Sobi’s chief medical officer, emphasized that the clinical data generated to date demonstrate meaningful reductions in serum uric acid levels. The company plans to work closely with its contract manufacturing partners to resolve the identified deficiencies. NASP is designed as a sequential, two-component infusion therapy intended to mitigate anti-drug antibodies while clearing uric acid deposits that cause joint damage and systemic comorbidities.