The Food and Drug Administration declined to approve UCB’s Biologics License Application for bimekizumab, its treatment for adults with moderate to severe plaque psoriasis.
The Belgian biopharma company announced Friday morning that the FDA’s Complete Response Letter noted that “certain pre-approval inspection observations must be resolved” before the application can be approved. UCB said it is cooperating with the FDA to address these concerns.
The FDA’s decision is the latest development in the bimekizumab approval saga.
In August 2021, GlobalData said preliminary data provided by UCB at the 2021 American Academy of Dermatology Summer Meeting “strongly support a potential approval” and will “reinforce physicians’ positive opinions about the drug.”
“Bimekizumab’s robust clinical program has made it a much-anticipated favorite among key opinion leaders interviewed by GlobalData,” said Tiffany Chan, an immunology analyst at GlobalData.
However, in October 2021, the FDA told UCB that it was unable to complete its review of the BLA, noting that it could not conduct inspections of European manufacturing facilities due to COVID-19-related concerns.
At the time, UCB CMO Prof. Dr. Iris Loew Friedrich said in a statement that the company provided the FDA with manufacturing schedules through the first quarter of 2022 and was looking forward to a decision from the agency.
“We are committed to bringing bimekizumab to patients in the U.S. with moderate to severe plaque psoriasis as soon as possible,” said Friedrich.
UCB said it is reviewing its full-year financial guidance.