–
The US pharmaceutical watchdog FDA was unable to complete inspections in Europe due to travel restrictions. The approval for the important psoriasis drug has been postponed indefinitely.
–
On Saturday afternoon, UCB issued the long-awaited press release on the US Food & Drug Administration’s (FDA) assessment of the psoriasis drug Bimzelx (better known as bimekizumab). The content is a disappointment to investors: there is – as yet – no green light.
–
“The FDA has determined that on-site inspections of European bimekizumab manufacturing facilities are required before the FDA can approve the application. The FDA has indicated that it was unable to conduct the inspections during the current review cycle due to travel restrictions related to COVID-19,” UCB said in a press release.
–
–
The letter received by UCB from the agency cites travel restrictions and inability to complete facility inspections as the sole reasons for delaying the assessment. “We are in contact with the FDA to complete the inspections at the production facilities as soon as possible,” said UCB. It is not clear how long the approval has been delayed.
–
We are committed to bringing bimekizumab to patients in the US as soon as possible.
Iris Loew Friedrich
Chief Medical Officer, UCB
–
–
–
“We have provided the agency with production schedules through the first quarter of 2022, and we are eager to help the FDA complete its review of bimekizumab. We are committed to bringing bimekizumab to patients in the US as soon as possible,” said Iris Loew Friedrich, Chief Medical Officer of UCB.
–
The importance of Bimzelx/bimekizumab for UCB can hard to overestimate. Analysts predict that the drug at its peak – somewhere around 2030 – will generate more than 2.5 billion euros in annual sales.
–
–
