Shots:
- 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
- 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
- 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 | Press Release
Related News:- Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
