CRL issued for Sobi's NASP BLA in uncontrolled gout
- Sponsor
- Sobi $SOBI
- Drug
- nanoencapsulated sirolimus + pegadricase (NASP)
- Indication
- uncontrolled gout in adults
FDA issued a Complete Response Letter for Sobi's NASP (nanoencapsulated sirolimus + pegadricase) BLA in adults with uncontrolled gout, citing deficiencies at contract manufacturing facilities and additional data on the biologic manufacturing control strategy — no clinical efficacy or safety concerns were raised.
What this means
NASP is Sobi's every-4-week infusion combining nanoencapsulated sirolimus with pegadricase, designed to reduce serum uric acid in adults with uncontrolled gout by lowering the immune response that has historically triggered anti-drug antibodies against pegylated uricase products (such as Krystexxa). FDA declined to approve the BLA, citing deficiencies at Sobi's contract manufacturing facilities and requiring additional data on the manufacturing control strategy for the biological component — no clinical, efficacy, or safety concerns were raised. This is the third quality-cause CRL identified this week involving third-party contract manufacturer deficiencies, alongside Elevar's rivoceranib-camrelizumab (2026-07-10) and Camurus's CAM2029 (2026-06-10).