AstraZeneca PLC Form 6-K Filing

AstraZeneca PLC announced that its Klygefa (gefurulimab) has received a recommendation for approval in the EU from the CHMP for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This recommendation is based on positive results from the PREVAIL Phase III trial, which demonstrated statistically significant and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living score. If approved, Klygefa will be the first and only dual-binding nanobody C5 inhibitor for gMG in the EU, offering once-weekly subcutaneous self-administration. The drug was generally well-tolerated, with a safety profile consistent with previous C5 inhibitors. Regulatory submissions based on the PREVAIL results are also under review in the US, China, and other countries.