UCB S.A.'s hopes of launching bimekizumab in the US before year-end have been thwarted by COVID-19-related travel restrictions that have prevented an inspection of the site where the closely watched psoriasis drug is manufactured.
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.

More from New Products
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The small interference RNA therapeutic can be used by patients regardless of inhibitor status.
The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.
After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.
More from Scrip
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
Supply chain disruption fears at the start of the COVID-19 pandemic caused drug over-ordering. Imminent tariffs on drugs may have had a similar effect on pharma sales in Q1 earnings season.
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.