UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx
Agency Cites Facility Inspection Concerns With Psoriasis Filing
The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.
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UCB Bullish On Bimzelx Despite Sluggish Start
While sales for the dual interleukin-17A and IL-17F inhibitor only reached €35m last year, UCB immunology chief Emmanuel Caeymaex is confident that figure will leap over the €200m barrier in 2023, if US approval for Bimzelx for psoriasis comes in the next quarter.
Cimzia Keeps Raking In The Cash As UCB Waits For New Products Impact
The Belgian group’s older products helped push 2022 revenues to the top of their guidance range as the peak sales forecast for the new epilepsy drug Fintepla is set at €800m.
UCB Aims High In Hidradenitis Suppurativa After Bimzelx Success
Topline results from two Phase III studies show the Belgian group's dual IL-17A and IL-17F inhibitor met its primary and secondary endpoints ahead of a filing for hidradenitis suppurativa next year. How well it compares with Humira and Cosentyx in this indication remains to be seen, however.