FDA Rebuffs Sobi Gout Drug Over Manufacturing Controls

The regulatory setback centers on the chemistry, manufacturing, and controls (CMC) of the biological components within the NASP therapy. Sobi must now address specific deficiencies identified at the contract manufacturing facilities involved in the production process. The company plans to engage with the FDA to clarify these requirements and establish a roadmap for resubmission.

Despite the delay, the company maintains its outlook on the drug’s viability. Lydia Abad-Franch, Sobi’s Chief Medical Officer, noted that clinical trials consistently demonstrated meaningful reductions in serum uric acid levels among patients. NASP is designed as a sequential, two-component infusion therapy intended for the roughly 200,000 Americans suffering from uncontrolled gout, a condition that persists despite standard oral urate-lowering treatments. The company remains committed to navigating the regulatory process to bring the treatment to market.