UCB's Bimzelx (bimekizumab) Receives EC's Approval for the Treatment of Moderate to Severe Plaque Psoriasis
- The approval is based on 3 P-III studies i.e.- BE VIVID- BE READY- BE SURE evaluating the efficacy & safety of bimekizumab vs PBO + ustekinumab- PBO- adalimumab in 1480 patients with a mod. to sev. PsO. The EC's approval is valid in 27 member states of the EU- Iceland- Liechtenstein & Norway
- The studies met its co-primary EPs & 2EPs i.e.- 60% of patients achieved complete skin clearance @16wks. & clinical response was maintained for ~1yrs.- 90% improvement in PASI 90 & IGA response of clear or almost clear skin
- The results from P-III BE READY & BE VIVID studies are published in The Lancet & P-III BE SURE study in NEJM. The therapy is currently under FDA & other countries’ review
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