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
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.
Company Info
Sector:Pharmaceutical / Rare Disease
Headquarters:Stockholm, Sweden
Founded:1939
Website:www.sobi.com/en
Upcoming Milestones & Key Dates
Q3 2026
Earnings
H1 2026 earnings and pipeline update
2026
Regulatory
Continued regulatory and commercial progress on gout combination drug following CRL
Clinical Development Pipeline
Kineret (anakinra)
Target: IL-1 receptor antagonistGamifant (emapalumab)
Target: Anti-IFNγ monoclonal antibodyDoptelet (avatrombopag)
Target: Thrombopoietin receptor agonistRecent News
FDA declines to approve Sobi's gout therapy on concerns over manufacturing
FDA declines to approve Sobi's gout therapy on concerns over manufacturing
Leadership Team
Guido Oelkers
Chief Executive Officer
Henrik Stenlund
Chief Financial Officer
Careers & Job Openings