UCB's Europe-approved IL-17 autoimmune drug hits FDA delay
UCB does not have Global Entry for bimekizumab.
While the drug has been cleared in Europe and other regions for nearly two years, UCB’s treatment for moderate to severe plaque psoriasis has run into another delay in the US.
The Belgian drugmaker said Tuesday it no longer expects the FDA to make a decision about the drug in the third quarter of this year. It’s the second roadblock for the therapy after the FDA rejected bimekizumab in early 2022, saying then that “inspection observations must be resolved.” In a terse update, UCB said the FDA is continuing its review, and the regulator “has not communicated timelines required to take action on the application.”
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