Shots:
- 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 study
- 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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