Inebilizumab

Horizon Therapeutics plc Announces New UPLIZNA® (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) to be presented at ECTRIMS 2023

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Monday, October 2, 2023

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new UPLIZNA analyses will be presented at the 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2023, Oct. 11-13.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new UPLIZNA analyses will be presented at the 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2023, Oct. 11-13.
  • UPLIZNA is the first and only targeted CD19+ B-cell-depleting therapy approved by the U.S. Food and Drug Administration, the European Commission and the Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).
  • P015: Association of Cytokine Proteins with Disease Activity in NMOSD Participants Receiving Inebilizumab Treatment (S. Pittock)
    P409: Long-Term Comparative Efficacy of Inebilizumab in the AQP4+ Subpopulation from the N-MOmentum Open-Label Extension Versus Azathioprine and Immunosuppressive Therapies and Versus Placebo in Patients with NMOSD (B. Cree)
    P011: Matching-Adjusted Indirect Comparison of Current Treatments for NMOSD and Evaluation of Long-Term Effectiveness (F. Paul)
    Horizon will host a symposium Thursday, Oct. 12 from 8:45 to 9:45 a.m. CEST, “Looking for unrecognized disease activity in NMOSD to optimize treatment choice and prevent disability,” chaired by Massimo Filippi, M.D., Ph.D., featuring presentations from Maria Rocca, M.D., Orhan Aktas, M.D.
  • and Jeffrey Bennett, M.D., Ph.D.

Horizon Therapeutics plc Announces UPLIZNA® (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) to be Presented at the 2023 American Academy of Neurology (AAN) Annual Meeting

Retrieved on: 
Thursday, April 20, 2023

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that multiple UPLIZNA analyses will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27 in Boston.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that multiple UPLIZNA analyses will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27 in Boston.
  • UPLIZNA is the first and only anti-CD19 B-cell-depleting humanized monoclonal antibody approved by the U.S. Food and Drug Administration (FDA), European Commission (EC) and Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4-immunoglobulin G seropositive (AQP4-IgG+).
  • “Of note, the oral presentation of data on B-cell subsets and aquaporin-4 antibody titers will shine a light on the role of plasmablasts and plasma cells in NMOSD attacks, and in turn, how targeting these cells with treatment may help prevent attacks.
  • A deeper understanding of the mechanism of this devastating disease will continue to enhance our ability to improve patient outcomes.”

One Year Post-Launch of Argenx's Vyvgart for gMG, US Neurologists Confused on Best Approach to Treatment Dosing Schedules, According to Spherix Global Insights

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Friday, February 24, 2023

EXTON, Pa., Feb. 24, 2023 /PRNewswire/ -- Argenx's launch of Vyvgart (efgartigimod) has been a success, with global first-year revenue of ~$400 million USD. As the second biologic approved for generalized myasthenia gravis (gMG) and the first neonatal Fc receptor (FcRn) blocker, Vyvgart's novel and targeted mechanism of action has resonated with HCPs. Indeed, neurologists and neuromuscular specialists surveyed by Spherix Global Insights consider Vyvgart to address a substantial unmet in the treatment of this chronic, rare autoimmune condition.

Key Points: 
  • Indeed, neurologists and neuromuscular specialists surveyed by Spherix Global Insights consider Vyvgart to address a substantial unmet in the treatment of this chronic, rare autoimmune condition.
  • Despite these positive perceptions of argenx's brand, surveyed respondents (n=69) remain less confident in Vyvgart's dosing profile.
  • Interestingly, even with increased experience among neurologists, half continue to report uncertainty as to when to re-dose patients after the first Vyvgart treatment cycle.
  • Indeed, when probed unaided on Vyvgart's biggest disadvantages, two in five offered its dosing profile as a leading disadvantage.

Biotheus has entered into a license and collaboration agreement with Hansoh Pharma for its EGFR/MET bispecific antibody in the Greater China territory

Retrieved on: 
Tuesday, November 15, 2022

PM1080 is an EGFR/MET bispecific antibody under development at Biotheus, who owns global rights to the asset.

Key Points: 
  • PM1080 is an EGFR/MET bispecific antibody under development at Biotheus, who owns global rights to the asset.
  • Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.
  • Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States.
  • Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue, ), a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD).

Generalized Myasthenia Gravis Pipeline Assessment Unveils Top Contenders to Challenge Current Market Biologics - New Spherix Report

Retrieved on: 
Thursday, October 6, 2022

EXTON, Pa., Oct. 6, 2022 /PRNewswire/ -- The recent launches of argenx's Vyvgart and Alexion's Ultomiris for the treatment of generalized myasthenia gravis (gMG), a debilitating and chronic autoimmune neuromuscular disorder, have provided patients with a new mechanism of action and new dosing options to tackle their disease. With at least five pipeline assets poised to gain FDA approval within the next two years, the competition is only expected to intensify.

Key Points: 
  • With at least five pipeline assets poised to gain FDA approval within the next two years, the competition is only expected to intensify.
  • Spherix surveyed 98 neurologists who prescribe biologics to their gMG patients in order to assess the current treatment and pipeline landscape.
  • The 2022 Market Dynamixstudy found that respondents emphasize the importance of the safety profile and disease-modifying effect when selecting a therapy for gMG treatment.
  • At present, prescribers reportedly reserve the approved biologics (which also includes Alexion's Soliris) as later-line options for patients with at least moderate disease severity.

KiOmed Pharma and Hansoh Pharma Announce License Agreement for KiOmedinevsOne in China’s Mainland, Macau and Taiwan

Retrieved on: 
Monday, September 26, 2022

Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory.

Key Points: 
  • Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory.
  • KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets.
  • We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China.
  • We are very glad to see KiOmeds product (KiOmedinevsOne) will help to solve this problem, said Eliza Sun, Executive Director of the Board of Hansoh Pharma.

NiKang Therapeutics and Hansoh Pharma Announce Strategic Collaboration and License Agreement for NKT2152 in Greater China

Retrieved on: 
Tuesday, May 3, 2022

Hansoh is a leader in the development and commercialization of small molecules for the treatment of cancer in China.

Key Points: 
  • Hansoh is a leader in the development and commercialization of small molecules for the treatment of cancer in China.
  • Our extensive expertise in oncology drug development can help accelerate development and advance NKT2152 as quickly as possible for cancer patients in China.
  • Hansoh will be responsible for all the development costs for NKT2152 in Greater China and will receive the exclusive rights to develop and commercialize NKT2152 in the region.
  • Hansoh Pharma is supported by a total of 12,150 dedicated employees in China and the United States.

eGenesis Appoints Eliezer Katz, M.D., FACS, as Chief Medical Officer

Retrieved on: 
Monday, April 4, 2022

CAMBRIDGE, Mass., April 04, 2022 (GLOBE NEWSWIRE) -- eGenesis, a gene-editing and genome-engineering company developing human-compatible organs and cells, today announced the appointment of Eliezer Katz, M.D., FACS, as Chief Medical Officer (CMO).

Key Points: 
  • CAMBRIDGE, Mass., April 04, 2022 (GLOBE NEWSWIRE) -- eGenesis, a gene-editing and genome-engineering company developing human-compatible organs and cells, today announced the appointment of Eliezer Katz, M.D., FACS, as Chief Medical Officer (CMO).
  • He oversaw the development of therapeutics to modulate the immune system in autoimmune diseases and organ transplantation.
  • eGenesis goal is to transform the field of transplantation by offering safe and effective organs and cells to patients in need.
  • eGenesis development pipeline includes lead programs for kidney and islet cell transplant as well as earlier-stage programs focused on other solid organs.

Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Monday, June 28, 2021

Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.

Key Points: 
  • Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.
  • We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.
  • Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD.
  • Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review.

New Analysis of UPLIZNA® (inebilizumab-cdon) for Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in Neurology Neuroimmunology & Neuroinflammation

Retrieved on: 
Thursday, May 6, 2021

These data are published in the May issue of Neurology Neuroimmunology & Neuroinflammation.

Key Points: 
  • These data are published in the May issue of Neurology Neuroimmunology & Neuroinflammation.
  • Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder.
  • Available at: https://nn.neurology.org/content/8/3/e978 .\nSerum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker.
  • Review: Recent advances in the understanding of the pathophysiology of neuromyelitis optica spectrum disorder.