FDA issues complete response letter to Sobi’s NASP for gout

Sobi has received a CRL from the US FDA regarding its BLA for NASP, an investigational therapy intended for adults with uncontrolled gout. The FDA did not identify concerns about the clinical efficacy or safety of NASP that would affect its potential for approval. Sobi intends to request a meeting with the FDA to discuss the feedback, consider the necessary steps for resubmission and work closely with CMOs to address the outlined deficiencies. Credit: Tapati Rinchumrus/Shutterstock.com. Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for…

Source: Pharmaceutical Technology