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
Sobi receives CRL for gout combination drug over manufacturing
Endpoints News reports that the FDA has issued a Complete Response Letter for Sobi's gout combination drug, citing manufacturing concerns.
Leadership Team
Guido Oelkers
Chief Executive Officer
Henrik Stenlund
Chief Financial Officer
Careers & Job Openings