FDA snubs Sobi’s gout drug over manufacturing issues
The FDA cited deficiencies at a contract manufacturing facility and is requiring additional data related to manufacturing control strategy.
Swedish Orphan Biovitrum (Sobi) is a global specialty biopharmaceutical company focused on rare diseases, with a portfolio spanning hematology, immunology, and specialty care. The company markets hemophilia treatments (Eloctate, Alprolix), immunology products (Kineret, Gamifant), and specialty therapeutics, and is expanding its rare-disease pipeline through both internal R&D and acquisitions.
H1 2026 earnings and pipeline update
Continued regulatory and commercial progress on gout combination drug following CRL
The FDA cited deficiencies at a contract manufacturing facility and is requiring additional data related to manufacturing control strategy.
FDA declines to approve Sobi's gout therapy on concerns over manufacturing
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