Sobi has announced that it has received a Complete Response Letter (CRL) from the US FDA regarding its Biologics License Application (BLA) for NASP (nanoencapsulated sirolimus plus pegadricase), which is being developed for adult patients with uncontrolled gout.

 

According to the CRL, the FDA is requesting additional data primarily focused on the manufacturing control strategy for the biological component of NASP, as well as remediation of deficiencies at a contracted manufacturing facility. Importantly, the agency identified no concerns related to the clinical efficacy or safety of NASP that would affect its approvability.

 

Sobi said it will request a meeting with the FDA to review the feedback, clarify the required steps for resubmission, and work with its contract manufacturing partners to address the cited issues.

 

"We continue to believe strongly in NASP's potential to address the significant unmet need faced by people living with uncontrolled gout," said Lydia Abad-Franch, Chief Medical Officer at Sobi. 

 

"The clinical data generated to date have demonstrated meaningful reductions in serum uric acid levels in patients with uncontrolled gout. The FDA's feedback provides a clear and actionable path forward and we will work closely with them towards a resubmission. We remain committed to bringing NASP to patients."

 

NASP remains under regulatory review as Sobi prepares next steps following the FDA’s manufacturing-focused concerns.