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Details:
UPLIZNA (inebilizumab-cdon), is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
UPLIZNA (inebilizumab-cdon) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. By targeting CD19, UPLIZNA reduces levels of plasmablasts in addition to memory B cells.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
UPLIZNA (Inebilizumab-cdon) is the first and only anti-CD19 B-cell-depleting humanized monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for the treatment of adult patients with anti-aquaporin-4 antibody positive NMOSD.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
UPLIZNA (Inebilizumab-cdon) is a highly specific CD19 B-cell depleting agent that targets an extended range of B cells, including plasmablasts and plasma cells, which contribute to NMOSD.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
EC approval was supported by results from N-MOmemtum, largest pivotal trial ever conducted in NMOSD, which showed 87.6% of AQP4-IgG+ NMOSD patients on Uplizna (inebilizumab) were attack free for 28 weeks, with vast majority remaining attack free for at least four or more year.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
In addition, an analysis from the N-MOmentum trial will be presented showing long-term treatment with UPLIZNA improved pain outcomes in patients with NMOSD. Pain is a common, debilitating symptom of NMOSD that can dramatically impact daily activities.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
UPLIZNA is a next-generation B-cell-depleting therapy specifically targets and depletes CD19-expressing B cells, including plasmablasts and some plasma cells not targeted by anti-CD20 therapies.
Lead Product(s): Inebilizumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
UPLIZNA is the first and only FDA-approved anti-CD19 B-cell-depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.
Lead Product(s): Inebilizumab
Therapeutic Area: Neurology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
UPLIZNA is the first and only FDA-approved anti-CD19 B-cell depleting humanized monoclonal antibody for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.
Lead Product(s): Inebilizumab
Therapeutic Area: Neurology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
Details:
Mitsubishi Tanabe Pharma Corporation (MTPC) has received manufacturing and marketing approval of UPLIZNA for the prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) from the Japanese Ministry of Health, Labour and Welfare.
Lead Product(s): Inebilizumab
Therapeutic Area: Immunology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
Horizon Therapeutics gets UPLIZNA, first and only FDA-approved B-cell-depleting humanized monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder.
Lead Product(s): Inebilizumab
Therapeutic Area: Immunology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: $3,005.0 million Upfront Cash: $3,005.0 million
Deal Type: Acquisition March 15, 2021
Details:
Horizon adds UPLIZNA® (inebilizumab-cdon) to its commercial rare disease medicine portfolio. The acquisition Adds deep, mid-stage biologics pipeline focused primarily on autoimmune and severe inflammatory diseases.
Lead Product(s): Inebilizumab
Therapeutic Area: Immunology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: $3,005.0 million Upfront Cash: $3,005.0 million
Deal Type: Acquisition February 01, 2021
Details:
First poster will highlights study results in AQP4-IgG seronegative patients in the N-MOmentum trial of inebilizumab in neuromyelitis optica spectrum disorder.
Lead Product(s): Inebilizumab
Therapeutic Area: Immunology Product Name: Uplizna
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
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