After a manufacturing-related complete response letter held up the U.S. launch of UCB’s psoriasis med bimekizumab last May, the FDA has officially closed out its inspection of the company's plant in Belgium.
Now, the agency's review will progress for an unknown amount of time, the company said.
Late last year, UCB's second application for bimekizumab was accepted at the FDA with a six-month FDA review period, prompting the company to expect a decision in the first half of 2023. But with the latest developments, the company "no longer expects" a decision by the end of the third quarter, UCB said in a statement.
The FDA closed out the plant inspection after an April 2023 inspection, but it "has not communicated timelines required to take action on the application," UCB said in its Tuesday update.
The process appears to be nearing an end. The company said its next update "will be shared at the time of the FDA action."
It’s been a bumpy road for bimekizumab in the U.S. The agency first delayed its decision on the drug in October 2021, citing the need for an on-site facility inspection. At the time, COVID-related travel restrictions prevented inspections at UCB's Belgian manufacturing site.
Inspectors finally visited the facility last year, resulting in a May complete response letter requiring the resolution of “certain pre-approval inspection observations.” UCB resubmitted its application in November and the FDA accepted it at the end of December.
The agency completed another inspection in April, resulting in the recent final Establishment Inspection Report.
Outside the U.S. UCB's bimekizumab is already approved in many markets around the world, including in the European Union, Canada, Mexico and Australia.
With the update, the Belgium-based company maintains its full-year financial outlook of revenues between 5.15 to 5.35 billion euros ($5.5 to $5.7 billion). Last year, UCB lowered its U.S. revenue forecast to account for the FDA rejection.
While UCB is still chasing a psoriasis nod for bimkizumab, the drug could also eventually boast an approval in hidradentis suppurativa. In March, the company presented its phase 3 data showing bimekizumab’s ability to maintain a 50% reduction of skin abscesses and inflammatory nodules in more than 75% of treated hidradentis suppurativa patients over 48 weeks.
Outside of bimkizumab, the company notched a win in June with the FDA's approval of its Rystiggo, a monoclonal antibody for the rare autoimmune condition myasthenia gravis (gMG).
The subcutaneously administered therapy became the first cleared to treat the two primary subsets of the disorder, although not the first for the disease as AstraZeneca and argenx beat it to the chase with their respective treatments.