Tag Archives: Sobi

November, 2018

20 November
FDA Approves Gamifant, the First and Only Treatment Indicated for Primary Hemophagocytic Lymphohistiocytosis

WALTHAM, Mass.–(BUSINESS WIRE)–Sobi, an international biopharmaceutical company dedicated to rare diseases, and Novimmune SA, a Swiss biotech company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gamifant®(emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody for the treatment of pediatric (newborn and older) and adult patients with primary hemophagocytic …
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25 January
FDA Grants Fast Track Status to Sobi’s Investigational MPS IIIA Drug

Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a …
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3 November
Interim Data of Prophylactic Eloctate Shows Improvements in Long-Term Joint Health for Hemophilia A Patients

WALTHAM, Mass. & STOCKHOLM–(BUSINESS WIRE)–Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced the publication of interim results from a longitudinal study of joint health in patients treated prophylactically with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, for treatment …
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5 July
FDA Grants Orphan Drug Designation to Sobi’s Treatment for MPS IIIA

STOCKHOLM–(BUSINESS WIRE)–Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the company’s development candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A, a …
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7 March
FDA Approves Increased Shelf Life and In-Use Storage at Room Temperature for Orfadin

WALTHAM, Mass.–(BUSINESS WIRE)–Sobi, a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the lives of rare disease patients and their families, announced today that the FDA approved a supplemental new drug application (sNDA) for Orfadin® (nitisinone) capsules in the U.S. The sNDA will allow for …
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2 March
Biogen and Sobi’s Hemophilia B Drug Succeeds in Phase III Trial in Children

Biogen Idec and Swedish Orphan Biovitrum AB (Sobi) recently announced positive results from its late-stage hemophilia B study. The companies announced top-line results of the Kids B-LONG Phase III clinical study that evaluated the safety, efficacy and pharmacokinetics of Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in children under …
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