FDA Accepts UCB Pharma’s Resubmitted BLA for Plaque Psoriasis

After getting a Complete Response Letter (CRL) from the FDA last spring due to manufacturing deficiencies, UCB Pharma says the agency has accepted its biologics license application (BLA) resubmission for bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis.

The CRL the company received in May rejected the first BLA for its investigational monoclonal antibody, explaining that deficiencies found in a preapproval inspection of the company’s manufacturing facility in Braine-l’Alleud, Belgium, had to be resolved before the BLA could proceed.

The FDA has set a six-month review period for the resubmission. A decision is expected during the second quarter of 2023.