CHMP Recommends Klygefa for EU Approval
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Klygefa (gefurulimab) for EU approval to treat adults with generalized myasthenia gravis (gMG). The recommendation follows positive results from the PREVAIL Phase III trial.
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended Klygefa (gefurulimab) for marketing authorization in the European Union. The drug is indicated for the treatment of adults suffering from generalized myasthenia gravis (gMG). The CHMP's recommendation is based on findings from the PREVAIL Phase III clinical trial, which demonstrated a statistically significant and clinically meaningful improvement in the Myasthenia Gravis Activities of Daily Living (ADL) score.
Should Klygefa receive final approval, it would become the first and only dual-binding nanobody C5 inhibitor for gMG within the EU. The treatment offers a once-weekly subcutaneous self-administration option, aiming for rapid and sustained symptom control. Myasthenia gravis is a chronic, rare autoimmune disorder characterized by muscle weakness.
The potential approval of Klygefa (gefurulimab), developed by Alexion, AstraZeneca Rare Disease, would introduce a new therapeutic option for gMG patients in Europe. The committee's positive opinion precedes a final decision from the European Commission on the marketing authorization.