pharmatimesFebruary 05, 2021
Tag: UCB , bimekizumab , plaque psoriasis
Data from two Phase III studies of UCB’s investigational treatment bimekizumab in moderate-to-severe plaque psoriasis have been published in The Lancet.
The data from the BE VIVID and BE READY studies demonstrated bimekizumab-treated patients achieved superior levels of skin clearance at week 16 compared to those who received placebo or Janssen’s Stelara (ustekinumab).
This was measured by at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) response of clear or almost clear skin for both comparisons.
Data from these studies were included in UCB’s marketing application submissions to both the US Food and Drug Administration and European Medicines Agency (EMA).
The company’s biologics license application (BLA) and marketing authorisation application (MAA) for bimekizumab in moderate-to-severe plaque psoriasis were accepted by the FDA and EMA, respectively, in September 2020.
“The simultaneous publication of data from two bimekizumab Phase III studies in one of medicine’s most authoritative titles, The Lancet, speaks to the significance of these psoriasis studies,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.
“We’re grateful to the patients and investigators who participated in the studies, and we’re committed to working with the regulatory agencies to bring bimekizumab to patients,” he added.
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