Biopharmaceutical company AstraZeneca PLC (STO: AZN; LON: AZN; NYSE: AZN) said on Monday it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Alexion, AstraZeneca Rare Disease's Klygefa (gefurulimab) as an add-on therapy for adults with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive.

Klygefa is a complement C5 inhibitor designed for once-weekly subcutaneous self-administration, with dual binding to C5 and serum albumin to extend half-life. If authorised, it would become the first dual-binding nanobody C5 inhibitor for this patient group in the European Union.

The recommendation is supported by the PREVAIL Phase III trial, which enrolled 260 adults across 20 countries and assessed weekly subcutaneous dosing following a weight-based loading dose. The study showed statistically significant improvement in Myasthenia Gravis Activities of Daily Living scores at week 26 versus placebo, with a treatment difference of -1.6 (95% CI: -2.4, -0.8; p