Quash­ing block­buster hopes, FDA spurns UCB’s IL-17 drug for plaque pso­ri­a­sis

Af­ter a months-long wait, UCB has fi­nal­ly heard back from the FDA re­gard­ing its plaque pso­ri­a­sis drug. And the ver­dict is no.

The agency re­ject­ed the BLA for the IL-17 in­hibitor, which is al­ready ap­proved in Eu­rope, the UK, Japan, Cana­da and Aus­tralia. Ac­cord­ing to UCB, the com­plete re­sponse let­ter states that “cer­tain pre-ap­proval in­spec­tion ob­ser­va­tions must be re­solved be­fore ap­proval of the ap­pli­ca­tion” — al­though it didn’t spec­i­fy the prob­lem.

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