India, June 27 -- Swedish Orphan Biovitrum AB (SWOBY) on Friday announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for NASP (nanoencapsulated sirolimus plus pegadricase) for the treatment of adult patients with uncontrolled gout.
The company said FDA seeks additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities, but raised no concerns about the clinical safety or efficacy of the product.
Sobi stated 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 deficienci...