Bimekizumab Approved by EC

UCB announced the European Commission have granted marketing authorization for bimekizumab for the treatment of moderate to severe plaque psoriasis.

UCB announced that the European Commission (EC) has granted marketing authorization for bimekizumab (Bimzelx; UCB) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.1 

Bimekizumab is an investigational humanized monoclonal immunoglobulin (Ig)G1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F, both of which are two key cytokines driving inflammatory processes, and it is the first approved treatment in the European Union (EU) to do so.

The approved 320 mg dose is given by subcutaneous injection every 4 weeks up to week 16 and every 8 weeks after that. For patients with a body weight greater than 120 kg who also did not achieve complete skin clearance at week 16, it is approved for a 320 mg dose every 4 weeks after week 16 to help improve treatment response.

“The approval of Bimzelx in Europe is the first marketing authorization for this new psoriasis treatment worldwide and represents a landmark moment for the dermatology community and UCB,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB, Atlanta, Georgia. “Our ambition is to transform the lives of people living with severe diseases, and we are incredibly proud to bring a new treatment option to people living with moderate to severe plaque psoriasis in Europe. We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can deliver.”

The EC approval comes after a positive opinion was granted by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use in June of 2021. This approval was supported by the BE READY (NCT03410992), BE SURE (NCT03412747), BE VIVID (NCT03370133) trials, which examined the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis. Recently the results from the long-term study BE BRIGHT (NCT03598790) were released.

The BE BRIGHT trial’s report shared the maintenance of the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear skin), Body Surface Area (BSA) of less than or equal to 1%, and Psoriasis Area and Severity Index (PASI) 100 through 2 years of bimekizumab treatment.2 

The analysis included patients randomized to bimekizumab 320 mg every 4 weeks who showed a response at week 16 in 1 of the other phase 3 studies that also were treated with bimekizumab 320 mg every 4 or 8 weeks as a maintenance dose after week 16 and continued the regimen in the BE BRIGHT trial.

There were 989 patients randomized to bimekizumab every 4 weeks and at week 16, 87.5% achieved an IGA response of 0/1, 74.9% achieved BSA of less than or equal to 1 %, and 62.7% achieved PASI 100. 

Of the week 16 patients who achieved IGA 0/1, 94.4% of those dosed every 4 weeks and 96.2% of those dosed every 8 weeks maintained the response to week 48.

For the BSA responders, 90.7% and 92.5% maintained BSA less than or equal to 1% to week 48 from week 16 for the 4-week and 8-week dose respectively. Also, more than 80% of patients who achieved PASI 100 at week 16 maintained response to week 48 in both groups.

The approval from the EC is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway. Bimekizumab is currently under review by the FDA for the treatment of adults with moderate to severe plaque psoriasis and the PDUFA date is set for October 15, 2021. 

Reference:

1. Press releases | UCB. Accessed August 25, 2021. https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-European-Commission-Approval-of-BIMZELX-bimekizumab-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis

2. Stocum, L. Bimekizumab demonstrates positive long-term in phase 3 psoriasis trial. Dermatology Times. Accessed August 25, 2021. https://www.dermatologytimes.com/view/bimekizumab-demonstrates-positive-long-term-in-phase-3-psoriasis-trial