Gilead Sciences announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Gilead KK (Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.
Gilead Japan will hold the marketing authorisation of Jyseleca in Japan and will be responsible for product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in RA. The companies will jointly commercialise the medicine to make it available to physicians and patients across Japan.
The approval in Japan is based on robust clinical trial results from the global FINCH Phase 3 and DARWIN Phase 2 programmes. The FINCH and DARWIN programmes evaluated Jyseleca in more than 3,500 patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with standard of care including biologic DMARDs. Patients receiving Jyseleca once daily showed improvements in clinical signs and symptoms, decreases in disease activity, and less progression of structural damage in their joints. Across the FINCH trials, Jyseleca demonstrated a consistent safety profile, and the frequency of adverse events of interest (including serious infections, herpes zoster, venous thromboembolism and major cardiovascular events) was comparable to control groups.
Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were 0.2 per cent and 0.3 per cent, respectively. The exposure adjusted incidence rate of serious infections per 100 persons per year (95 per cent CI) was 1.7 per cent (1.3, 2.1) in the Jyseleca 200 mg group and 2.5 per cent (1.9, 3.3) in the Jyseleca 100 mg group, respectively. When prescribing Jyseleca, physicians are advised to monitor patients for the development of new, or exacerbation of existing, serious infections including pneumonia, tuberculosis, sepsis and other viral infections.
Gilead is developing Jyseleca in collaboration with Galapagos NV. The two companies are conducting global studies investigating the potential role of Jyseleca in a variety of diseases, including the previously reported Phase 3 SELECTION trial in ulcerative colitis.