UCB Reports the US FDA’s Acceptance of sBLA for Bimzelx (bimekizumab-bkzx) to Treat Hidradenitis Suppurativa
Shots:
- The US FDA has accepted the sBLA of Bimzelx to treat moderate to severe hidradenitis suppurativa (HS) along with a 2nd sBLA of device presentations that aims approval for bimekizumab-bkzx 2mL safety syringe and 2mL autoinjector
- The sBLA was based on the results from P-III (BE HEARD I and BE HEARD II) trials assessing the safety & efficacy of bimekizumab-bkzx vs PBO in moderate to severe HS patients (n=1014 combined)
- The trial depicted improvement in the 1EP of HiSCR50 and reached the 2EP of HiSCR75 at wk.16 with an increase in these improvements after 48wks. The safety profile was consistent without any new observed outcomes
Ref: UCB | Image: UCB
Related News:- UCB’ Bimzelx (bimekizumab) Receives the US FDA’s Approval for the Treatment of Adults with Moderate to Severe Plaque Psoriasis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
