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European Commission grants two new marketing authorisations for UCB’s Bimzelx

The European Commission (EC) has granted UCB’s Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).

The marketing authorisations, which follow a pair of recommendations from the European Medicines Agency’s human medicines committee earlier this year, make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications.

The authorisation for PsA – a type of arthritis that affects some patients with psoriasis – specifically applies to those with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs.

The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations.

“The approval of [Bimzelx] in PsA provides rheumatologists and dermatologists in the EU with a new treatment option,” said Professor Iain McInnes, University of Glasgow, College of Medical, Veterinary and Life Sciences.

“Data from the phase 3 clinical studies demonstrated the consistently high thresholds of disease control achieved with [Bimzelx] versus placebo in patients with PsA who were biologic naïve or TNF inhibitor-inadequate responders,” McInnes said.

The new approval in active axSpA – a type of arthritis that mainly affects the joints of the spine – includes certain patients with non-radiographic axSpA who have had an inadequate response or have been intolerant to non-steroidal anti-inflammatory drugs, and those with ankylosing spondylitis who have been inadequately controlled by or been intolerant to conventional therapy.

The EC’s decision was based on results from two phase 3 studies in which a greater proportion of patients treated with Bimzelx, compared with placebo, achieved significant improvement in signs, symptoms and disease activity across the full spectrum of the disease.

The approvals represent the first marketing authorisations for Bimzelx in PsA and axSpA worldwide, according to UCB, as well as the second and third indications for Bimzelx in the EU, following its approval for the treatment of moderate-to-severe plaque psoriasis in 2021.

Emmanuel Caeymaex, executive vice president, immunology solutions and head of US at UCB, said: “The EC’s parallel approval of [Bimzelx] in PsA and axSpA builds on the momentum created since its first approval in moderate-to-severe plaque psoriasis and marks an exciting milestone offering healthcare professionals and patients the first IL-17A and IL-17F inhibitor for treatment of these diseases.”



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