UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug
Delays Expected Approval Of Bimekizumab
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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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.
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.
The Brussels-based company's head of immunology has told Scrip that going into a crowded market against several highly effective biologics across different classes holds no fears for UCB despite some concerns that US prescribers will stick to what they know when it comes to psoriasis therapies.