Japan approves Gilead and Eisai’s Jyseleca for rheumatoid arthritis

pharmafile | September 25, 2020 | News story | Medical Communications, Sales and Marketing Eisai, Gilead, Japan, Jyseleca 

Gilead and Eisai have secured approval for their oral JAK1 preferential inhibitor Jyseleca (filgotinib) from the Japanese Ministry of Health, Labour and Welfare as a treatment for rheumatoid arthritis (RA), it has emerged.

The approval relates to patients for whom conventional therapies for the prevention of structural joint damage have not been effective.

According to Phase 2 and 3 data drawn from over 3,500 patients and submitted in support of the application, patients receiving Jyseleca once daily saw their symptoms and disease activity improve, while slowing the progression of structural joint damage.

Furthermore, the drug’s safety profile was shown to be in line with previous findings, with a similar prevalence of adverse events.

Gilead’s Japanese branch will hold the commercial license as well as handle supply of the product in Japan, while Eisai will be responsible for distributing it in the country for RA.

“RA causes many patients debilitating fatigue and pain that can significantly interfere with their daily lives,” said Dr Yoshiya Tanaka, Professor at the First Department of Internal Medicine at the University of Occupational and Environmental Health. “It is important to have new treatment options that can offer patients effective symptom control and bring them new hope.”

Matt Fellows

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