AstraZeneca's Klygefa drug recommended for EU approval by CHMP
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended Klygefa (gefurulimab) for approval in the EU as an add-on therapy for adults with generalised myasthenia gravis (gMG). The recommendation is based on the PREVAIL Phase III trial, which showed statistically signi