Uplizna

Uplizna (inebilizumab-cdon) was found effective both at reducing attacks and lessening disability in people with neuromyelitis optica spectrum disorder (NMOSD) living in Europe, according to data from the N-MOmentum Phase 2/3 trial. Nearly 90% of participants given Uplizna remained free from attacks six months after starting the therapy,…

Uplizna (inebilizumab-cdon) works to treat people with neuromyelitis optica spectrum disorder (NMOSD) regardless of whether such patients carry genetic variants linked to poor responses to other B-cell depleting therapies, new trial data show. An analysis of N-MOmentum Phase 2/3 data found that the approved therapy was as effective…

The European Commission has approved Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4-IgG). The approval covers all member states in the European Union, as well as Iceland, Liechtenstein, and Norway. Horizon Therapeutics, the company marketing Uplizna,…

Uplizna (inebilizumab-cdon) was just as safe and effective in people with neuromyelitis optica spectrum disorder (NMOSD) treated after only one symptomatic attack as those treated after two or more attacks, according to an analysis of N-MOmentum Phase 2/3 trial data. This sub-analysis had sought to understand how a…

Blood levels of two proteins, GFAP and neurofilament light chain (NfL), may help predict the course of neuromyelitis optica spectrum disorder (NMOSD), according to new research. Findings also suggest that many NMOSD patients have evidence of brain lesions with active inflammation without any associated symptoms, which indicates that disease…

Uplizna (inebilizumab-cdon) effectively reduced the severity of attacks in people with neuromyelitis optica spectrum disorder (NMOSD) who continued to experience attacks after being treated with the therapy during the N-MOmentum Phase 2/3 clinical trial, recent data analysis shows. The data also demonstrated lower levels of key disease-related biomarkers,…

Prior treatment with rituximab does not limit the effectiveness or safety of Uplizna (inebilizumab-cdon) in people with  neuromyelitis optica spectrum disorder (NMOSD), a further analysis of data from the N-MOmentum Phase 2/3 trial has found. Uplizna’s efficacy in preventing NMOSD attacks and its safety profile were comparable in trial…

Long-term treatment with Uplizna (inebilizumab-cdon) safely and effectively reduced the frequency of attacks in the 12 neuromyelitis optica spectrum disorder (NMOSD) patients who were negative for antibodies against aquaporin-4 (AQP4) in the N-MOmentum Phase 2/3 trial. Future, appropriately-controlled studies are needed to confirm Uplizna’s benefits in this subgroup…

Uplizna (inebilizumab-cdon), a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD), is now available in the U.S. through specialty distributor BioCareSD and specialty infusion pharmacy BioTek Remedys. The companies added the medication to their portfolio of specialty therapeutics to expand upon their product offering…

A committee of the European Medicines Agency has recommended approving Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for aquaporin-4 water channel autoantibodies (AQP4-IgG). This recommendation from the Committee for Medicinal Products for Human Use, known as CHMP, will now be reviewed by…