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The CHMP has recommended Klygefa(gefurulimab; SC, QW) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are AChR antibody-positive; filings are under review in the US, China & other countries
Opinion was supported by the P-III (PREVAIL) trial assessing Klygefavs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE studyΒ
Trial met its 1EP, showing improvement in MG-ADL total score at week 26, with benefit seen as early as Wk. 1 & was sustained through Wk. 26; data were published in JAMA Neurology
Ref: PRnewswire | Image: AstraZeneca |Press Release
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The post AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis appeared first on PharmaShots.
AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis | PharmaVoice