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’s Bimzelx has forged ahead with success in a late-stage psoriatic arthritis trial while it still awaits US approval for psoriasis, a hotly anticipated blockbuster indication.