Sunday, 10 Dec 2023

FDA Decision on Bimekizumab Approval for Psoriasis Delayed

The US Food and Drug Administration’s (FDA’s) review of the biologics license application (BLA) for bimekizumab for the treatment of psoriasis is continuing. A decision on the approval application has been delayed until the third quarter of this year, according to a June 26 announcement by the manufacturer, UCB.

The FDA’s decision had been expected by the end of June. No reason for the delay was provided in the company’s press release.

Bimekizumab is a monoclonal antibody that inhibits interleukin (IL)-17A and IL-17F, two drivers of inflammation. The manufacturer, UCB, is seeking approval in the United States for the treatment of adults with moderate to severe plaque psoriasis.

The biologic has been approved for the treatment of moderate to severe psoriasis in the European Union as well as in Canada, Australia, Japan, and Saudi Arabia. It is marketed as Bimzelx. Earlier this month, the European Commission approved the treatment for the additional indications of active psoriatic arthritis and active axial spondyloarthritis. In January 2022, it was approved in Japan for the treatment of generalized pustular psoriasis and psoriatic erythroderma.

In October 2021, the company announced that the FDA could not complete the review of the BLA for bimekizumab because COVID-19 travel restrictions prevented the FDA from completing an inspection of manufacturing facilities in Europe. The FDA accepted the resubmission of UCB’s biologics license application in December 2022. The approval decision is set for the second quarter of 2023.

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