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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