UCB’s Bimzelx (bimekizumab) Receives EC’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis

August 24, 2021 Auto Bot approval, bimekizumab, EC, Plaque Psoriasis, regulatory, UCB 0

Shots:

  • 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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