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EU CHMP recommends approval for AstraZeneca's Klygefa as first dual-binding nanobody C5 inhibitor
AZNAstrazeneca PLC
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval in the EU for Klygefa (gefurulimab), an add-on treatment for adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis. The positive opinion is based on the PREVAIL Phase III trial, which demonstrated a statistically significant improvement in Myasthenia Gravis Activities of Daily Living scores at week 26 compared to placebo (treatment difference: -1.6). If approved, Klygefa will be the first and only dual-binding nanobody C5 inhibitor for this indication in the EU, offering once-weekly subcutaneous self-administration. AstraZeneca PLC is a global biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines.