Gilead and Eisai Launch Jyseleca (Filgotinib), a Once-Daily Selective JAK1 Inhibitor, in Japan for Rheumatoid Arthritis

Compiled by newborn

Gilead Sciences K.K. and its partner Eisai recently announced the launch of Jyseleca (filgotinib, 200 mg and 100 mg tablets) in Japan. This novel, once-daily oral selective JAK1 inhibitor was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) this September for the treatment of adult patients with rheumatoid arthritis (RA) who have had an inadequate response to conventional therapies, including for the prevention of structural joint damage.

It is estimated that there are 600,000 to 1 million patients with rheumatoid arthritis (RA) in Japan. Although RA treatment has advanced, many patients still do not achieve adequate disease remission, and significant unmet medical needs remain. The launch of Jyseleca will provide a new therapeutic option for the RA patient population in this region.

Under the co-promotion agreement signed by Gilead and Eisai in December 2019, Gilead will hold the sales license for Jyseleca, while Eisai will be responsible for the product distribution of Jyseleca in Japan for the treatment of RA and other potential future indications.

From a regulatory perspective, Jyseleca received approval from the European Commission on the same day it was approved in Japan, for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to or intolerance of one or more disease-modifying antirheumatic drugs (DMARDs). In early November this year, the European Medicines Agency also accepted the new indication of Jyseleca for the treatment of ulcerative colitis (UC).

Molecular structure of filgotinib (Image source: Wikipedia)

In the United States, the FDA issued a Complete Response Letter (CRL) in August this year, refusing to approve Jyseleca. The FDA requested data from the MANTA and MANTA-RAy studies, which are evaluating whether Jyseleca affects sperm parameters, with top-line results expected to be released in the first half of 2021. Additionally, the FDA expressed concerns about the overall benefit/risk profile of high-dose Jyseleca (200 mg).

The active pharmaceutical ingredient of Jyseleca is filgotinib, a highly selective JAK1 inhibitor discovered and developed by Galapagos. In late December 2015, Gilead Sciences entered into a $2 billion agreement with Galapagos to co-develop filgotinib. Currently, both parties are evaluating the potential of Jyseleca for the treatment of various inflammatory diseases, with Phase III trials covering rheumatoid arthritis (RA), ulcerative colitis (UC), and Crohn’s disease.

According to a previous report by the pharmaceutical market research firm EvaluatePharma, Jyseleca is projected to become one of the key products driving Gilead’s future growth, with global sales expected to reach $1.4 billion in 2024.

Reference source: BRIEF—Jyseleca launches for RA in Japan