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

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

Myasthenia gravis is a rare neuromuscular disorder caused ... and rozanolixizumab (Rystiggo). Drugmaker Amgen expects to complete an FDA submission for inebilizumab in gMG in the first half ...

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 ...

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

The FDA approves Amgen's Uplizna as the first and only drug for the treatment of immunoglobulin G4-related disease.

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

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 ...

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 ...