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Gilead, Galapagos arthritis drug rejected by FDA gets go-ahead from Japanese, European regulators

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A drug for rheumatoid arthritis that the U.S. Food and Drug Administration turned down last month has received the go-ahead from two regulators abroad.

Foster City, California-based Gilead Sciences said Friday it and its Mechelen, Belgium-based partner, Galapagos, had received approval for Jyseleca (filgotinib) from the European Commission and from the Ministry of Health, Labor and Welfare in Japan, where it is partnered with drugmaker Eisai. The drug is a JAK1 inhibitor for rheumatoid arthritis in patients who have not responded adequately to conventional therapies.

Shares of Gilead (Nasdaq: GILD) were up 1.3% on the Nasdaq Monday morning, while shares of Galapagos (AMS: GLPG) were up 5.3% on the Euronext Amsterdam. Shares of Eisai (TYO: 4523) were up more than 1.3% on the Tokyo Stock Exchange.

“RA causes many patients debilitating fatigue and pain that can significantly interfere with their daily lives,” University of Occupational and Environmental Health internal medicine professor Dr. Yoshiya Tanaka said in a statement on behalf of Gilead. “It is important to have new treatment options that can offer patients effective symptom control and bring them new hope.”

The twin decisions stand in contrast to that of the FDA, which late last month issued a complete response letter – a notice of rejection – for the drug, causing shares of both companies to fall sharply. The FDA requested data from two of the studies that were used for approval, MANTA and MANTA-RAy, before completing its review. But it also expressed concerns about the overall risk-benefit profile of filgotinib when administered at the 200mg dose level. Although the companies’ pursuit of approval for filgotinib was not seen as risk-free, the news nevertheless came as a surprise to analysts, given that the European Medicines Agency’s Committee for Medicinal Products for Human Use had issued a positive opinion for the drug. Given the CRL, it will likely be at least another year before the drug is launched in the U.S.

The approvals in Japan and Europe are based on results from the Phase III FINCH and Phase II DARWIN studies. The European Commission decision covers the European Union, as well as the European Free Trade Association nations of Norway, Iceland and Liechtenstein, but excludes Switzerland, which has its own regulatory agency, Swissmedic.

Photo: Tomsmith585, Getty Images

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