After UCB’s psoriasis drug bimekizumab hit an FDA wall in May thanks to issues with facility inspections, the drug is back on the FDA’s waiting list. The agency accepted UCB’s biologics license application resubmission and designated it as Class 2, complete with a six-month review period.
With this development, the FDA's decision on the application is expected by the second quarter of 2023. UCB sent in the resubmission in November after receiving an FDA complete response letter in May. At the time, the agency couldn’t consider the approval because “certain pre-approval inspection observations" were outstanding at the time.
That setback came after a delay for the company in October 2021 because the FDA couldn't inspect European facilities due to COVID-related travel restrictions.
UCB's drug is a humanized monoclonal IgG1 antibody that selectively inhibits interleukin 17A (IL-17A) and interleukin 17F, which are two key cytokines that drive inflammatory processes. It’s already gained approvals in Europe and Great Britain plus Japan, Canada, Australia, Saudi Arabia and Switzerland.
Thanks to the six-month review period, the first half of 2023 should be quiet for UCB, while the second will likely show growth thanks to strong U.S. sales, ODDO BHF analysts wrote in a note to clients. The company could have three approvals next year in bimekizumab plus the rare disease duo of zilucoplan and rozanolixizumab. Before these approvals, which should start with bimekizumab, ODDO BHF analysts anticipate “another five tough months.”
Back in June, the company already had to reduce its profit forecast for 2022 thanks to generic competition, inflation and the complete response letter.
Meanwhile, earlier this month, UCB touted results from two phase 3 trials of bimekizumab in hidradenitis suppurativa. In the inflammatory skin disease, the drug showed improvement over placebo in reducing patient’s skin abscesses and inflammatory nodules. UCB plans to start global filings for that indication during the third quarter of 2023.