18th Sep 2026 15:27
(Alliance News) - AstraZeneca PLC on Friday announced that Klygefa has been recommended for approval in the EU, as a treatment for generalised myasthenia gravis.
The Cambridge, England-based pharmaceutical company said the recommendation, from the Committee for Medicinal Products for Human Use of the European Medicines Agency, covers Klygefa as an add-on to standard therapy for gMG in anti-acetylcholine receptor antibody-positive adults.
AstraZeneca noted that if Klygefa, also known as gefurulimab, is approved, it "will be the first and only dual-binding nanobody C5 inhibitor for this patient population." gMG is a rare autoimmune disorder that causes severe muscle weakness and reduced muscle function.
The CHMP, Astra said, based its positive opinion on results from the phase 3 Prevail trial, which the firm announced in late July. The study found that gefurulimab met its primary and all secondary endpoints, with a statistically significant and clinically meaningful improvement in patients' Myasthenia Gravis Activities of Daily Living total scores after 26 weeks.
"This positive CHMP opinion is an important step towards bringing Klygefa...to people living with gMG in the EU," commented Marc Dunoyer, chief executive officer of Astra's Rare Disease business Alexion. "Building on our pioneering work demonstrating the efficacy of C5 inhibition with Soliris and Ultomiris, Klygefa is designed to offer rapid and sustained symptom control with convenient once-weekly subcutaneous self-administration via autoinjector."
AstraZeneca noted that Klygefa is approved in Japan and other countries for certain adult gMG patients. Also, regulatory submissions based on the Prevail trial are under review in multiple countries, including in China and the US.
AstraZeneca shares were up 0.7% at 12,518.00 pence in London on Friday afternoon.
By Emma Curzon, Alliance News reporter
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