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JUL 16 2026
CRL · 75 DAYS AGO

Sobi — nanoencapsulated sirolimus + pegadricase (NASP) $SOBI

for uncontrolled gout in adults

NDA

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.

About

Uncontrolled gout is a painful form of arthritis where high uric acid levels lead to sudden, severe joint inflammation and long-term damage. Nanoencapsulated sirolimus with pegadricase combines a drug that calms the immune system with an enzyme that breaks down uric acid. This dual approach may lower uric acid while reducing the inflammatory flares that define the condition.

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