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  • Hansa Biopharma AB
    Scheelevägen 22 22363 Lund, Sweden
    +46 (0) 461 656 70
    http://www.hansabiopharma.com
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    Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation

    PRESS RELEASE · The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients · Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response · FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review   Lund, Sweden, 19 December 2025. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced the submission of a

    NICE recommends use of Hansa Biopharma’s Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

    · Idefirix® becomes the first and only product recommended by NICE for the desensitization of highly sensitized patients waiting for a kidney transplant1 · NICE considers Idefirix® to be a clinically and cost-effective treatment within current clinical practice · The positive recommendation will enable access to this novel therapy for highly sensitized patients in England, Wales and potentially Northern Ireland Lund, Sweden, June 16, 2022. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), pioneer in enzyme technology for rare immunological conditions, today announces the

    Hansa Biopharma announces temporary marketing authorization in Switzerland for Idefirix[®] (imlifidase) in kidney transplantation

    · Approval by Swissmedic[1] enables highly sensitized patients in Switzerland to receive Idefirix[®] treatment prior to kidney transplantation · Idefirix[®] is now granted marketing authorization within the EU, the U.K.*, Israel and Switzerland Lund, Sweden May 13, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), pioneer in enzyme technology for rare immunological conditions, today announces that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix[®] in adult patients with a positive crossmatch against an

    Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

    · Idefirix® is among a few selected medicines to be granted ASMR 3 (Amélioration du service médical rendu) by the French Transparency Commission, which represents a level of clinical added benefit, and has also received SMR Important1 · The opinion by the Transparency Commission follows after Idefirix® was granted a funded Early Access Program by the French Haute Autorité de Santé (HAS) in February this year · Commercial launch activities for Idefirix® in Europe continue to progress Lund, Sweden, April 20, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), pioneer in

    Hansa Biopharma announces U.S. FDA acceptance of Investigational New Drug (IND) application for Phase 3 study of imlifidase in anti-GBM disease

    · Pivotal Phase 3 study to commence in 2022 and is expected to enroll 50 patients across the U.S. and Europe · Scientific advice on protocol obtained from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with the aim of conducting a global study · Clinical Phase 2 data suggests that deactivation of autoantibodies by imlifidase could alter the course of this serious autoimmune disease Lund, Sweden, April 19, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), pioneer in enzyme technology for rare immunological conditions, today announces

    Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix[®] (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

    · Hansa Biopharma completes the AMNOG reimbursement process for Idefirix[®] in Germany · Hansa and National Association of Statutory Health Insurance Funds (GKV-SV) agree on reimbursement price · German hospitals can receive extra funding for the final reimbursement price based on a positive NUB status 1 decision Lund, Sweden, March 15, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, today announces having reached an agreement on the reimbursement for Idefirix in Germany with the National Association of

    Key data demonstrating the potential of Hansa Biopharma’s imlifidase to significantly alter course of anti-GBM disease published in JASN

    · Results of an investigator-initiated open-label Phase 2 study of imlifidase in patients with anti-glomerular basement membrane (anti-GBM) disease published in leading nephrology publication Journal of the American Society of Nephrology (JASN).1 · Imlifidase rapidly and completely reduced pathogenic anti-GBM antibody levels to below reference range. · At six months 67% of the included patients had functioning kidneys versus 18% in a historical control cohort. · The publication recognises the study’s significance in autoimmune diseases as it suggests that deactivation of

    Hansa Biopharma to initiate Phase 3 study of imlifidase to treat anti-Glomerular Basement Membrane (anti-GBM) disease after successful pre-IND meeting with U.S. FDA

    · Pivotal Phase 3 study to commence in 2022 and is expected to enroll approximately 50 patients across the U.S. and Europe · Advice procedure also initiated with the European Medicines Agency · Marks important milestone in the expansion of imlifidase into autoimmune diseases Lund, Sweden November 15, 2021. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announces its decision to initiate a pivotal Phase 3 clinical study of imlifidase to treat anti-GBM disease, following a successful pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (

    Hansa Medical AB to change name to Hansa Biopharma AB

    Lund, Sweden, December 20, 2018-Hansa Medical AB (publ) (Nasdaq Stockholm:HMED) (“Hansa Medical” or the “Company”), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the name change resolutions approved at an Extraordinary General Meeting ("EGM") held on December 4, 2018, have been approved by the ‘Bolagsverket’ in Sweden.The name change will be implemented in the next days and weeks and the Company stock ticker symbol has changed from “HMED” to “HNSA”.  The information was submitted for publication, through

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