FDA Issues CRL for Bimekizumab for Psoriasis

The FDA has issued a complete response letter (CRL) regarding the biologics license application (BLA) for UCB’s bimekizumab, now called Bimzelx, for the treatment of adults with moderate-to-severe plaque psoriasis.

The regulatory agency indicated that that certain pre-approval inspection observations must be resolved before approval of the application. UCB is cooperating with the FDA and working to address these observations, the company said in a press release.

In October 2021, the FDA missed the assigned Prescription Drug User Fee Action (PDUFA) date because COVID-19 travel restrictions hindered the ability of the FDA to inspect European manufacturing facilities.

Related: FDA Misses PDUFA Date for Bimekizumab

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A and interleukin 17F, two key cytokines driving inflammatory processes. The FDA had accepted UCB's application for bimekizumab in September 2020. In August 2021, bimekizumab received marketing authorization in countries of the European Union/European Economic Area and Great Britain treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments. In February and March 2022, bimekizumab received marketing authorization in Canada and Australia, respectively, treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.