CHMP Recommends EU Approval of Bimekizumab for Plaque Psoriasis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of adult patients with moderate to severe plaque psoriasis.

Bimekizumab is an investigational IL-17A and IL-17F inhibitor that has been found to be effective and safe in adults with moderate to severe plaque psoriasis in three Phase II studies. The positive opinion of CHMP was supported by the positive Phase III trial results.

“This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe,” said Emmanuel Caeymaex, executive vice-president, Immunology Solutions and head of US, UCB, in a June 25, 2021 press release. “We’re delighted by today’s decision which recognizes the strength of the psoriasis clinical development program. Bimekizumab is testament to our commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes.”

CHMP’s positive opinion will be shared with the European Commission, which will decide upon the marketing authorization for the European Union member states and the European Economic Area countries. The commission’s decision is expected to be delivered in two months.

Source: UCB