Bimzelx gains approval in Japan for treating psoriasis

UCB’s Bimzelx was given marketing authorization in Japan for treatment of psoriatic indications, according to a press release from the company.

In Japan, Bimzelx (bimekizumab) is the first available treatment for moderate to severe plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma that targets two key cytokines that power inflammatory processes, the release said.

Japan’s approval was due to bimekizumab’s positive outcomes in phase 3/3b clinical studies showing greater degrees of skin clearance vs. placebo.

This approval in Japan marks Bimzelx being accepted for the third time worldwide, with the first two approvals granted in August 2021 in European Economic Area countries and Great Britain.

“At UCB, our ambition is to transform the lives of people living with severe diseases,” Emmanuel Caeymaex, executive vice president of immunology and U.S. solutions at UCB, said in the release. “We are incredibly proud to bring a new psoriasis treatment option to health care professionals and patients in Japan to help support more patients in reaching their treatment goals.”

The FDA is reviewing bimekizumab, and in Australia, Canada and Switzerland, governing reviews are also in progress.