European Medicines Agency recommends bimekizumab in two new indications

Key takeaways:

• The agency issued a positive opinion of bimekizumab in psoriatic arthritis and axial spondyloarthritis.
• If approved, bimekizumab will be the first interleukin-17F/17A inhibitor in these indications.

The European Medicines Agency has recommended granting marketing authorization for bimekizumab for the treatment of adults with axial spondyloarthritis and active psoriatic arthritis, according to a UCB press release.

The recommendation from the agency’s Committee for Medicinal Products for Human Use (CHMP) may lead bimekizumab to its second and third approved indications in the European Union.

“The positive CHMP opinion for two new indications for bimekizumab in Europe is a significant step towards our goal of delivering differentiated treatment options to patients,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S., UCB, said in the release. “If approved, bimekizumab would be the first treatment for psoriatic arthritis and axial spondyloarthritis that inhibits [interleukin (IL)]-17F in addition to IL-17A.”

The recommendation for the psoriatic arthritis indication follows data from two phase 3 studies, BE COMPLETE and BE OPTIMAL. Both studies met their primary endpoints by week 16, with BE OPTIMAL also showing that bimekizumab-treated patients sustain improvement up to 1 year.

The recommendation for axial spondyloarthritis includes nonradiographic and ankylosing indications. More specifically, the positive opinion applies to adults with active disease that are unresponsive to anti-inflammatory drugs or conventional therapy, according to the release.

This decision is supported by two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, which showed the primary endpoint was met after 16 weeks and results were sustained through 52 weeks.

Pending the European Commission’s final decision, the marketing authorization will be valid in all European Union member states, Iceland, Norway, Northern Ireland and Liechtenstein if approved. According to the release, the company expects a decision within 2 months.