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.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.