UCB Reports the FDA's and EMA's Acceptance of BLA and MAA for Bimekizumab to Treat Moderate to Severe Plaque Psoriasis
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- The marketing application submissions are based on three P-III studies- BE VIVID- BE READY- BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO
- All 3 P-III studies met their 1EPs- demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured by the PASI 90 and IGA response of clear or almost clear skin (IGA 0/1)
- The studies also met its 2EPs demonstrating superior total skin clearance @16wks.- as measured by PASI 100- confirming the superiority of bimekizumab over Stelara (ustekinumab) and adalimumab. Further- bimekizumab was superior to comparative arm in achieving a rapid response- defined as PASI 75 @4wks.- clinical responses were maintained up to 1yr.in all studies
Ref: UCB | Image: Twitter
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