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.
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.
The psoriasis market is crowded and fiercely competitive but the Belgian group's bimekizumab has bested Novartis's interleukin-17A behemoth Cosentyx in a head-to-head study. Whether UCB goes it alone or signs up a large partner with a large marketing budget remains to be seen.