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UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

Delays Expected Approval Of Bimekizumab

Executive Summary

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

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UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx

The US Food and Drug Administration has published a report after an inspection of UCB’s Belgian facility where Bimzelx is manufactured and the findings suggest that a long-awaited approval for the psoriasis drug should not be taken for granted.

UCB Makes Another Push To Get Bimzelx Over Finishing Line In US

The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.

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

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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