Bimzelx gets FDA acceptance for resubmission

[Fred]

Following on from this thread Bimzelx FDA cannot approve the application in its current form the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.

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UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The FDA designated the resubmission as ‘Class 2’ with a six-month review period. The FDA action is expected in the second quarter of 2023. 

“The FDA acceptance of our resubmitted application for bimekizumab is positive news that moves us one step closer to providing the first dual IL-17A and IL-17F inhibitor to address the unmet needs of people with moderate to severe plaque psoriasis in the U.S. We will continue to work with the FDA through the review process with the goal of bringing bimekizumab to the dermatology community in the U.S. as soon as possible,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

In November 2022, UCB announced resubmission of the BLA for bimekizumab, for the treatment of adults with moderate to severe plaque psoriasis, following receipt of a complete response letter in May 2022. 

Source: ucb.com

Bimzelx (bimekizumab)

[Fred]

Update:

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UCB today announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under review with the U.S. Food & Drug Administration (FDA). UCB previously communicated the FDA action was expected in Q2, 2023. UCB now anticipates the FDA action in Q3, 2023. There are no open Information Requests from the FDA regarding the BLA for bimekizumab.

UCB is committed to ongoing collaboration with the FDA in order to bring bimekizumab to people in the U.S. living with moderate to severe plaque psoriasis as soon as possible.

Source: ucb.com