FDA backs new rare disease drug Uplizna

The US Food and Drug Administration on Thursday approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), also called Sjögren’s syndrome, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive).

The FDA granted approval of Uplizna to Gaithersburg, Maryland, USA-based Viela Bio (Nasdaq: VIE), which was spun out two years ago from AstraZeneca (LSE: AZN) subsidiary MedImmune in February 2018.

Although Viela’s shares rose 4.9% in pre-market trading today, the stock was down more than 9% at $46.75 by late morning.