Rheumatism drug Galapagos receives Japanese approval

The Japanese Ministry of Health has approved the rheumatism filgotinib, which the Belgian-Dutch pharmaceutical company Galapagos will market in Japan under the name Jyseleca, together with the American Gilead and the Japanese Eisai. Galapagos and Gilead are jointly developing the drug for rheumatoid arthritis.

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The Bel20 company with headquarters in Mechelen announced the news Friday morning together with Gilead, the American pharmaceutical giant with which Galapagos last year closed a billion dollar deal. Gilead is the holder of the Jyseleca marketing authorization in Japan and is responsible for the product supply in Japan. The Japanese Eisai is responsible for the distribution of the drug in Japan. “The companies will jointly commercialize the drug to make it available to doctors and patients in Japan,” said Galapagos.

The approval in Japan comes after “robust results” of clinical trials, Gilead said.

Filgotinib should be used for the treatment of adults with moderate to severe rheumatoid arthritis who have previously had an inadequate response to or are intolerant to the more traditional rheumatic drugs (DMARDs). At the end of July, the pharmaceutical company already cleared a major hurdle in Europe, when the European Medicines Agency (EMA) issued a positive advice on the drug.

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