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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post