Biopharmaceutical company Sobi (STO: SOBI) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application for Nanoecapsulated Sirolimus plus Pegadricase (NASP), a novel infusion therapy for patients with uncontrolled gout. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 June 2026.

NASP, formerly known as SEL-212, combines nanoencapsulated sirolimus with pegadricase and is administered every four weeks. It is designed to reduce serum uric acid levels while mitigating the formation of anti-drug antibodies that can limit the efficacy of biologics.

The application includes data from the pivotal Phase 3 DISSOLVE I and II trials, which both met their primary endpoint of maintaining serum uric acid levels below 6 mg/dL for at least 80% of the time during month six. Response rates were 51% for the high-dose group and 43% for the low-dose group. Patients also showed improvements in tophi resolution, reduced flare frequency and better quality of life outcomes.

NASP received FDA Fast Track designation in May 2024. Sobi estimates that around 200,000 people in the US live with uncontrolled gout despite existing therapies.

Headquartered in Sweden, Sobi reported SEK26bn in revenue in 2024 and employs approximately 1,900 staff worldwide.