← Back to The Docket JUL 16 2026
CRL · 15 DAYS AGO
— 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 cause sudden, severe joint inflammation and long-term crystal deposits. Nanoencapsulated sirolimus with pegadricase is a two-drug combination designed to lower uric acid by breaking it down and calming the immune system's overreaction. This dual approach could potentially reduce the frequency of debilitating flares and the damaging crystal buildup in joints.
