SNAPSHOT

Amgen’s Uplizna enters a crowded European myasthenia gravis market

The European Commission approved Amgen’s Uplizna for generalized myasthenia gravis (gMG), positioning the biotech to compete with argenx, UCB and Johnson & Johnson in a fast-growing autoimmune market.

Why it matters: The decision intensifies competition in gMG, a rare muscle-weakening autoimmune disease, and gives physicians a new mechanism and dosing option that could shift market share.

Backstory: Argenx’s FcRn blocker Vyvgart beat the competition to market in 2022 by winning EU approval. The subcutaneous version came soon after in 2023. UCB’s Rystiggo and J&J’s Imaavy followed in 2024 and 2025. FcRn blockers lower pathogenic IgG autoantibodies by blocking FcRn that would normally slow the breakdown of IgG.

Zoom in: Uplizna, on the other hand, works differently by depleting CD19-positive B cells. Already approved in the U.S. and EU for other rare autoimmune diseases, Uplizna was approved based on a Phase III trial showing a 2.8-point reduction on a disease severity scale vs. placebo at 52 weeks. Analysts called the data competitive with Vyvgart and stronger than C5 inhibitors like AstraZeneca’s Ultomiris. Uplizna is given intravenously with two starter doses two weeks apart, then maintenance every six months. By contrast, Imaavy is dosed every two weeks, while Vyvgart and Rystiggo are administered in multi-week cycles with breaks (both offer subcutaneous options).

Big picture: Generalized myasthenia gravis is emerging as a key growth market for biologics. With multiple entrants and differentiated mechanisms, companies are competing on efficacy, durability and convenience, not just speed to market.

What’s next: Amgen plans to target both treatment-naive patients and those switching therapies, banking on twice-yearly dosing and a distinct mechanism to drive European uptake.

SNIPPETS

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