AstraZeneca gets two positive EU regulatory opinions for Klygefa
AstraZeneca said the EU Committee for Medicinal Products for Human Use issued positive opinions for Klygefa (gefurulimab) in adults with AChR—positive gMG as an add-on treatment, and noted that approval would make it the first dual-binding nanobody C5 inhibitor available in Europe.
AstraZeneca said the EU’s Committee for Medicinal Products for Human Use backed Klygefa (gefurulimab) for adults with AChR-positive gMG as an add-on treatment. The company said that, if approved, it would be the first dual-binding nanobody C5 inhibitor available in Europe. The recommendation follows a positive opinion on Klygefa for adults with generalized myasthenia gravis.