Amgen's Uplizna posts strong results in myasthenia gravis trial
WEB2 days ago · Amgen revealed early data from a trial of Uplizna, which showed its effectiveness in treating the neurologic disorder myasthenia gravis.
Amgen's Rocatinlimab Data Beats Placebo In Atopic Dermatitis …
WEB2 days ago · In an investor update on Tuesday, Amgen Inc (NASDAQ:AMGN) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab). HORIZON Phase 3 trial evaluated rocatinlimab for atopic...
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 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...
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...
Inebilizumab Improved Outcomes Over Placebo in Phase 3 Trials …
WEB3 days ago · Inebilizumab-cdon is currently approved under the name Uplizna for treating AQP4+ neuromyelitis optica spectrum disorder in the US and internationally. It is being evaluated in the phase 3 MITIGATE trial (NCT04540497), which is the first global placebo controlled, randomized controlled trial in IgG4-RD.
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,
Amgen reports success for eczema and myasthenia gravis …
WEB3 days ago · Amgen on Tuesday reported that a pair of antibody drugs it is developing as treatments for immune-mediated diseases succeeded in late-stage trials, but the therapies did not clearly beat existing...
UPLIZNA® (inebilizumab-cdon) | NMOSD Treatment
WEBUPLIZNA is FDA approved for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD and provides the following benefits: Proven effective in reducing the risk of attacks. 2 doses a year*. Established safety profile. * After 2 startup doses.
Amgen reports positive data from Phase III IgG4-RD treatment trial
WEBJun 6, 2024 · Amgen has reported positive topline outcomes from the Phase III MITIGATE clinical trial assessing UPLIZNA (inebilizumab-cdon) to treat Immunoglobulin G4-related disease (IgG4-RD). The double-blind, randomised, multicentre, placebo-controlled study enrolled 135 adults across 80 sites in 22 countries.
- Some results have been removed