FDA issues CRL for Sobi’s NASP filing

Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, said late Friday it had received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 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 the company provide additional data mainly related to manufacturing control strategy of the biological component of NASP and to address contract manufacturing facility deficiencies. The FDA identified no concerns regarding the clinical efficacy or safety of NASP that impact approvability. Sobi 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.