BRIEF—Chugai's Actemra approved for adult Still's disease in Japan

Japan’s Chugai, which is majority owned by Roche, has obtained regulatory approval for the humanized anti-human interleukin (IL)-6 receptor monoclonal antibody, Actemra (tocilizumab [genetical recombination]) Intravenous Infusion from the Ministry of Health, Labor and Welfare (MHLW) for an additional indication of “adult Still’s disease that has not responded sufficiently to existing therapies” and an additional dosing regimen for the indication.

Adult Still’s disease is an autoimmune disease and specified as an intractable disease by the government. The disease typically presents with a triad including fever of 39°C or higher, arthritis, and light pink skin rash.

“Corticosteroids are the current standard of care for adult Still’s disease. There are high needs for new therapies for inadequate responders and relapsed patients,” said Dr Yasushi Ito, Chugai’s executive vice president, co-head of Project & Lifecycle Management Unit.

This approval is based on data including results from the “clinical trial of tocilizumab for adult onset Still’s disease,” an investigator-initiated study.

The study was a multicenter study conducted at eight sites, led by Keio University Hospital. The hospital was designated as a hub of pharmaceutical/incurable immune disease areas in July 2011, as part of the “Project for Early/Exploratory Clinical Trial Centers” by the Japanese government.