Inebilizumab, a first-in-class CD19+ B-cell–targeting agent, is safe and effective for up to 1 year in patients with ...

Autoimmune generalized myasthenia gravis is a disease that manifests with fluctuating muscle weakness. Inebilizumab is a monoclonal antibody that depletes CD19+ B cells, which are central to ...

Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be ...

This study was supported by Amgen. Nowak reported relationships with the National Institutes of Health, Genentech, Alexion ...

With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth ...

The FDA approved Amgen's Uplizna as the first treatment for IgG4-RD. The decision is backed by the MITIGATE trial, showing reduced flares and sustained efficacy.

Inebilizumab showed significant efficacy in improving MG-ADL and QMG scores in gMG patients compared to placebo over 26 weeks. The trial included 238 patients, with 80% AChR+ and 20% MuSK+, and ...

The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...

As Amgen waits for an FDA decision on a second ... MINT trial in adults living with autoimmune disorder generalised myasthenia gravis (gMG) – which can lead to muscle weakness, breathing ...

Inebilizumab-cdon was previously approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD) in adults who are ...