Amgen's Uplizna posts strong results in myasthenia gravis trial
WEB5 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 ...
Inebilizumab Improved Outcomes Over Placebo in Phase 3 Trials …
WEB6 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 …
Potential Regulatory Submission for Inebilizumab in Myasthenia …
WEB4 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).
Positive new phase 3 MRI data from UPLIZNA trial for NMOSD
WEB1 day ago · 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...
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...
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...
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,
MITIGATE: Inebilizumab Reduces Risk of IgG4-Related Disease Flare
WEBJun 5, 2024 · Topline data from the randomized, placebo-controlled Phase 3 MITIGATE study demonstrated inebilizumab-cdon (UPLIZNA®) met all primary and key secondary endpoints in treating immunoglobulin G4-related disease (IgG4-RD). 1
Amgen's Uplizna proves its worth in another rare disease, setting …
WEBJun 5, 2024 · The CD19-targeted rare disease medicine Uplizna was one of the crown jewels in Amgen’s $27.8 billion buyout of Horizon Therapeutics. Now, with a phase 3 triumph in progressive fibroinflammatory...
- Some results have been removed