Gilead's oral JAK1 inhibitor Jyseleca is available in Japan

Sciences K.K., a Japanese subsidiary of Gilead Sciences, and partner Akihon recently announced the launch of Jyseleca (filgotinib, 200mg and 100mg tablets) in Japan, a new, daily The oral, selective JAK1 inhibitor was approved by Japan's Ministry of Health, Labour and Labour (MHLW) in September to treat adult patients with rheumatoid arthritis (RA) who do not respond well to conventional therapies, including the prevention of structural joint injuries.It is estimated that there are 60-1 million RA patients in Japan. Although RA treatment is progressing, many patients still do not receive adequate disease relief and there are still significant unsealed medical needs. Jyseleca's launch will provide a new treatment option for the REGION's RA patient population.Under a joint promotion agreement between Gilead and Wesser in December 2019, Gilead will hold a sales license for Jyseleca, which will be responsible for the distribution of Jyseleca's products in Japan for the treatment of RA and other potential future adaptations.On the same day that Jyseleca was approved in Japan, Jyseleca was also approved by the European Commission to treat adult patients with moderate to severe RA who did not respond well or were insatiable to one or more disease-modified rheumatoid drugs (DMARD). In early November, Jyseleca's new adaptation to the treatment of ulcerative colitis (UC) was also accepted by the European Medicines Agency.In the U.S., the FDA issued a full response letter (CRL) in August rejecting Jyseleca's approval. The FDA requested data from the MANTA and MANTA-RAy studies, which are evaluating whether Jyseleca has an effect on sperm parameters and are expected to release top-line results in the first half of 2021. In addition, the FDA has expressed concern about the overall benefit/risk status of high doses of Jyseleca (200 mg).Jyseleca's active pharmaceutical ingredient is filgotinib, a highly selective JAK1 inhibitor discovered and developed by Galapagos. Gilead reached a $2 billion deal with Galapagos at the end of December 2015 to jointly develop filgotinib. Currently, the two sides are evaluating Jyseleca's potential to treat a variety of inflammatory diseases, including Phase III trials including the treatment of RA, UC, crohn's disease.A report by Evaluate Pharma, a pharmaceutical market research group, predicted that Jyseleca would be one of Gilead's key products for future growth, with global sales expected to reach $1.4 billion by 2024. (Sina Pharmaceutical News)source: BRIEF-Jyseleca launches for RA in Japan