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AZ's gMG drug Klygefa nears EU approval
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Fusion42 · 21 September 2026 · Fusion42 review
AstraZeneca's Alexion unit received a positive opinion from the EMA's CHMP for Klygefa, a subcutaneous dual-binding nanobody C5 inhibitor for generalised myasthenia gravis, setting up near-term EU approval. This therapy offers a home-administered weekly dose and competes with existing therapies in the EU market, potentially reaching over $1 billion in peak sales.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You can now position for market access in EU rare diseases as AstraZeneca is about to add a home-administered weekly therapy for gMG to the field. This narrows the window for new entrants with less convenient dosing or administration modes.
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1 source · 21 Sep 2026
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