UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa
Shots:
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The recommendation was supported by the P-III studies (BE HEARD I and BE HEARD II) assessing the safety and efficacy of Bimzelx 1014 patients with PsA evaluating bimekizumab vs PBO at week 16
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Both trials met their 1EPs & 2EPs measured by HiSCR50 and HiSCR75 respectively at wk. 16. Clinical responses were sustained up to 48wk. in (BE HEARD I and BE HEARD II) trial
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For its final decision, the EC will refer to bimekizumab's positive opinion grant by the CHMP on moderate to severe HS. The marketing authorization would apply to all the EU member states and countries of the EEA
Ref: UCB | Image: UCB
Related News:- UCB Reports the US FDA’s Acceptance of sBLA for Bimzelx (bimekizumab-bkzx) to Treat Hidradenitis Suppurativa
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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.
