Amgen wins FDA approval for Uplizna in generalized myasthenia gravis

US biotech Amgen (Nasdaq: AMGN) has won approval from the US regulator for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. It is the antibody’s third US approval overall.

The decision sets up competition with British pharma AstraZeneca’s (LSE: AZN) Ultomiris (ravulizumab) and Dutch biotech argenx (Euronext: ARGX) with its FcRn blocker Vyvgart (efgartigimod alfa). Amgen is pitching Uplizna’s twice-yearly maintenance dosing after an initial loading phase as a differentiator.

“By selectively targeting CD19-positive B cells, Uplizna offers a new approach to treatment that addresses a biological root cause of disease,” said Jay Bradner, executive vice president of research and development at Amgen. “Uplizna is conveniently dosed twice a year and delivers durable efficacy.”