By Maitane Sardon
Shares in UCB fell in early trading on Friday after the company said that the US Food and Drug Administration didn’t approve a biologics license application for its psoriasis drug bimekizumab, which prompted it to review its 2022 guidance.
At 0828 GMT, shares were down 12% at EUR89.68.
The Belgian pharmaceutical company said it had received a letter from the FDA–as part of a procedure known as Complete Response Letter–stating that it cannot approve the application for bimekizumab in its current form. “The CRL states that certain pre-approval inspection observations must be resolved before approval of the application,” UCB said.
The company said bimekizumab had received marketing authorization for the treatment of moderate to severe plaque psoriasis in adults in some EU countries as well as in the UK, Japan, Canada and Australia.
UCB said it was reviewing the financial guidance it had issued for 2022 in the context of the FDA letter. It had previously said it was expecting 2022 revenue of between 5.15 billion euros ($5.35 billion) and EUR5.4 billion and adjusted earnings before interest, taxes, depreciation, and amortization of between 26% and 27% of revenue.
The FDA’s observation could be related to the inspection of a Belgium manufacturing site which occurred in the first quarter this year, Bryan Garnier analyst Jean-Jacques Le Fur said in a research note. In this case, the only risk at stake would be that of an additional delay in the approval of the drug, since no clinical setback seems to be implied, Le Fur said.
Psoriasis is a common, chronic inflammatory condition, caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.
Write to Maitane Sardon at [email protected]
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