Alexion Reports Results of Ultomiris (ravulizumab-cwvz) in P-III Study for Generalized Myasthenia Gravis
- The P-III study evaluates the safety and efficacy of Ultomiris vs PBO in 175 adults in a ratio (1:1) with gMG with no prior treatment with a complement inhibitor medicine across North America- EU- Asia-Pacific- and Japan for 26 wks.
- The study met its 1EPs of change from baseline in MG-ADL total score @26wks. & demonstrated efficacy as early as 1wks. that sustained for 52 wks. Additionally- the therapy was well tolerated with a consistent safety profile with that seen in P-III studies for PNH & aHUS
- The company plans to make regulatory filings in the US- EU & Japan in late 2021 or early 2022- based on P-III results
Ref: Alexion | Image: Anticorr
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