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UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

Agency Cites Facility Inspection Concerns With Psoriasis Filing

 
• By Kevin Grogan

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.

UCB flag
• Source: UCB

UCB S.A.'s hopes of launching Bimzelx in the US this year have been scuppered again by regulators across the Atlantic who have rejected the potential blockbuster for inflammatory diseases, citing facility inspection issues.

Bimzelx (bimekizumab) comfortably secured approval for psoriasis in the EU and the UK in August last year but the regulatory...

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