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Biopharmaceutical company UCB said recently that it plans to seek U.
S.
and European Union approval in the third quarter of this year for Bimzelx (bimekizumab), a dual IL-17A and IL-17F inhibitor, for the treatment of adult patients with active psoriatic arthritis after The company reported that a Phase 2 III trial in this indication met its primary endpoint
.
"We believe these consistent and robust results have the potential to improve the standard of care for patients," said Emmanuel Caeymaex, head of the company's U.
Last November, UCB announced that the late-stage BE OPTIMAL study of Bimzelx had met its primary endpoint
.
The trial's primary results showed that patients who received the drug showed a significant improvement of more than 50% in signs and symptoms of disease compared with placebo, according to the American College of Rheumatology 50 (ACR50) response at week 16
The latest study, called BE COMPLETE, included 400 adults with active psoriatic arthritis who had an inadequate response or intolerance to anti-TNF-alpha treatment
.
First-line results showed that Bimzelx-treated patients had significantly increased ACR50 responses at week 16 compared to placebo
First-line results showed that Bimzelx-treated patients had significantly increased ACR50 responses at week 16 compared to placebo
COVID-19 FDA
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