Amgen's Uplizna posts strong results in myasthenia gravis trial
WEB4 days ago · Amgen Uplizna Myasthenia Gravis Horizon Therapeutics. Three months after Amgen revealed that Uplizna had aced a phase 3 trial in immunoglobulin G4-related disease (IgG4), the company said the anti ...
FDA Approves New Therapy for Rare Disease Affecting Optic …
WEBJun 11, 2020 · The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult...
Amgen Seeks Expanded US Approval For Autoimmune Disease …
WEBJun 5, 2024 · Uplizna is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) by several regulatory bodies, including the FDA, the European Medicines Agency, Health Canada, and the Brazilian...
AMGEN ANNOUNCES POSITIVE RESULTS FOR PHASE 3 …
WEBJun 5, 2024 · 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. IMPORTANT SAFETY INFORMATION. UPLIZNA is contraindicated in patients with: A history of life-threatening infusion reaction to UPLIZNA.
Amgen preps Uplizna filing for a second indication
WEBJun 6, 2024 · Amgen has moved closer to a second indication for its B cell-depleting therapy Uplizna, acquired as part of its $27.8 billion takeover of Horizon Therapeutics last year, after positive results in...
Inebilizumab Improved Outcomes Over Placebo in Phase 3 Trials …
WEB5 days ago · Inebilizumab-cdon has demonstrated efficacy in treating IgG4-related disease (IgG4-RD) and generalized myasthenia gravis (gMG) in phase 3 trials. 1. “IgG4-RD is a lifelong systemic inflammatory condition that can affect nearly any organ in the body and typically impacts multiple organs. IgG4 is characterized by CD19+ B …
Uplizna Treatment for NMOSD Shows Sustained Clinical Benefit …
WEBMay 22, 2024 · According to the findings, long-term treatment with Uplizna (inebilizumab-cdon; Amgen, Dublin, Ireland) for adults diagnosed with neuromyelitis optica spectrum disorder (NMOSD) was associated with continued and sustained clinical benefit, including decreased incidence of adjudicated attacks and decreased annualized attack rates,
Positive new phase 3 MRI data from UPLIZNA trial for NMOSD
WEBSep 21, 2024 · UPLIZNA is the first and only targeted CD19+ B-cell-depleting therapy that is approved by the US FDA, the European Commission, and the Brazilian Health Regulatory Agency (ANVISA) for the...
UPLIZNA® (inebilizumab-cdon) | NMOSD Treatment
WEBUPLIZNA® (inebilizumab-cdon) is a treatment for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. See safety information.
Potential Regulatory Submission for Inebilizumab in Myasthenia …
WEB3 days ago · NeurologyLive is your direct connection to the latest neurology news and interviews with expert neurologists in multimedia formats. News. ... (NCT04524273) assessing inebilizumab (Uplizna), an FDA-approved therapy for neuromyelitis optica spectrum disorder (NMOSD), in patients with generalized myasthenia gravis (gMG).
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