In May of this year, the FDA issued a full response letter that delayed the launch of UCB’s bimekizumab treatment for psoriasis in the U.S. Since then, the FDA has completed the inspection process of the manufacturing facility in Belgium. Now, according to the company, the investigation by the agency will continue for an undetermined period of time.
Last year, the FDA approved UCB’s second proposal for bimekizumab after assigning it a review time of six months. As a result, the firm anticipated receiving a decision within the first half of 2023. Taking into account the most recent events, however, UCB noted in a statement that the firm “no longer expects” to get a decision before the end of the third quarter.
After conducting an inspection of the manufacturing facility in April 2023, the FDA shut out the inspection, but the agency “has not communicated timelines required to take action on the application,” according to the update provided by UCB on Tuesday.
It would appear that the process is drawing to a close. The firm stated that it will share its subsequent status update at the time that the FDA action is taken.
In the U.S., bimekizumab has had a rocky route to market. In October 2021, the FDA postponed its judgement about the medicine for the first time, claiming the necessity of an on-site facility inspection. Inspections at the UCB production plant in Belgium were not possible during that time period because COVID-related travel restrictions were in place.
The facility was ultimately inspected in the previous year, which resulted in a comprehensive response letter being sent out in May. This letter required the facility to resolve certain pre-approval examination remarks. The FDA finally accepted UCB’s resubmitted application at the end of December after the company had resubmitted it in November.
The organization carried out yet another examination in April, which led to the recent completion of the Establishment Inspection Report.
Bimekizumab has widespread international approval outside of the U.S. These markets include the European Union, Australia, Mexico and Canada.
The firm is maintaining its full-year financial estimate of between 5.15 and 5.35 billion euros in light of the new information. UCB reduced its revenue projections for the U.S. last year because of the FDA’s rejection.
UCB is still hoping to get bimkizumab approved for psoriasis, but there’s a chance it might also be used to treat hidradenitis suppurativa. More than 75% of hidradenitis suppurativa patients treated with the drug had a 50% decrease in skin abscesses and inflammatory nodules over 48 weeks, according to phase 3 data released by the firm in March.
The company also scored a victory in June when the FDA approved its monoclonal antibody Rystiggo for the extremely uncommon autoimmune illness myasthenia gravis (gMG).
The medicine, which is injected under the skin, became the first of its kind approved to treat both major types of the illness. However, both AstraZeneca and argenx have previously developed therapies for the ailment.