Sobi (STO: SOBI), a Sweden-based biopharmaceutical company, announced on Friday that the company received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the company's Biologics License Application (BLA) for NASP (nanoencapsulated sirolimus plus pegadricase) for the treatment of adult patients with uncontrolled gout.

In the CRL, the FDA required that company to provide additional data, mainly related to manufacturing control strategy of the biological component of NASP, and to address contract manufacturing facility deficiencies. Sobi says that the FDA identified no concerns regarding the clinical efficacy or safety of NASP that impact approvability.

Sobi added that it will request a meeting with the FDA to discuss the feedback, determine the appropriate steps toward resubmission and work with the contract manufacturing organisations to address the deficiencies.

NASP is a novel, investigational medicine designed to reduce serum uric acid (sUA) levels in people living with uncontrolled gout.