FDA Issues Complete Response Letter for UCB's Bimekizumab

There’s a delay in the US regulatory review of UCB’s bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. FDA has indicated it cannot approve the BLA for bimekizumab in its current form. The agency issued a Complete Response Letter (CRL) that states that certain pre-approval inspection observations must be resolved before approval of the application. 

UCB says it is cooperating with the FDA and is working to address these observations as expeditiously as possible. The company also is reviewing its financial guidance for 2022.

UCB says it is committed to bringing bimekizumab to patients worldwide. In August 2021, bimekizumab received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) and Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In 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, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.