Shots:
- The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026)
- BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum uric acid (sUA <6mg/dL) for ≥80% during six months, with pooled response rates of 51% (high dose) & 43% (low dose)
- Trial also showed rapid, sustained sUA reductions from first treatment through study end, with improvements in tophi resolution, fewer gout flares & better QoL; both doses were well tolerated
Ref: Sobi | Image: Sobi | Press Release
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