UCB Reports the FDA’s and EMA’s Acceptance of BLA and MAA for Bimekizumab to Treat Moderate to Severe Plaque Psoriasis

Shots:

• 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

Click here ­to­ read full press release/ article | Ref: UCB | Image: Twitter