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FDA Approves Sanofi and Sobi’s Altuviiio for Hemophilia A

FDA Approves Sanofi and Sobi’s Altuviiio for Hemophilia A

The FDA has approved Sanofi and Sobi’s Altuviiio for adults and children with Hemophilia A, for use in prophylaxis, perioperative management during surgery and on-demand treatment to control bleeding episodes.

Altuviiio is a replacement therapy for patients with the hereditary bleeding disorder caused by a deficiency in factor VIII, a blood clotting protein.

The agency’s decision was based on results from a phase 3 study, which showed significant bleed protection for participants with severe Hemophilia A.

Altuviiio previously received priority review, Breakthrough Therapy, Fast Track and Orphan Drug designations from the FDA.

About Sobi

Swedish Orphan Biovitrum AB (Sobi Pharma) is an international biopharmaceutical company dedicated to treatments in the areas of haematology, immunology and specialty care, based in Stockholm, Sweden. In 2020 it had a revenue of SEK 15.261 billion and 1,509 employees.

Sobi traces its origins to a subsidiary of Kärnbolaget Aktiebolag Biokemisk Industri in the 1930s, which changed its name to Kabi [sv] in 1951 and merged with Vitrum to become KabiVitrum in the 1970s.Sobi has been involved in the process development and manufacturing of recombinant protein drugs since the technology was first developed around 30 years ago, then as part of KabiVitrum.

February 27, 2023


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