New anti-inflammatory drugs! Gillid has entered into cooperation with Weicai to develop and distribute oral Jak1 inhibitor filgotinib in Japan!

December 26, 2019 / BIOON / -- Gilead and Eisai recently jointly announced that they have reached an agreement on the distribution and joint promotion of filgotinib, an oral selective Jak1 inhibitor, in the Japanese market Through this cooperation, Gilead Japan will continue to be responsible for the manufacturing and regulatory approval of filgotinib, while Weicai will be responsible for the distribution of the drug in Japan for the treatment of rheumatoid arthritis (RA) and other potential future indications, including ulcerative colitis, Crohn's disease, psoriatic arthritis, etc Currently, the application for indication of filgotinib in the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) is being reviewed by the European Drug Administration (EMA) and the Ministry of health, labor and welfare (MHLW) of Japan Just recently, Gilead submitted an application for the indication to the US FDA It is also the third time the company has filed an application for filgotinib with regulators in the past five months It is worth mentioning that Gilead has also submitted a priority review voucher (PRV) along with its application to FDA, which can shorten the expected review time Although therapies are currently available, RA patients may face persistent disease symptoms and inadequate response to existing therapies One in five patients does not get complete remission in their lifetime and still need treatment Regulatory application documents for the treatment of RA by filgitinib are based on data from the global phase III finch clinical program The project evaluated the efficacy and safety of filgotinib in 3452 patients with moderate to severe active RA In these studies, filgtotinib reached the primary end point and showed long-term efficacy and safety in a wide range of RA patients, including patients who had previously inadequate response to methotrexate (MTX), patients who were intolerant to one or more biological agents, and patients who had not previously received MTX treatment (MTX primary treatment) In different subgroups of RA patients, once daily oral administration of filgotinib can improve the clinical signs and symptoms, achieve low disease activity and treatment remission, and inhibit structural damage The safety results are consistent throughout the finch program, further enhancing the long-term safety and tolerability of filgotinib in a wide range of RA patients Molecular structure formula of filgotinib (photo source: Wikipedia) filgotinib is a highly selective Jak1 inhibitor, which was discovered and developed by Galapagos At the end of December 2015, Gilead and Galapagos reached a total agreement of up to 2 billion US dollars to jointly develop filgotinib This cooperation will help to enhance Geely's position in the field of inflammatory diseases, which will become a new growth point of Geely in the future after the fields of hepatitis C and HIV At present, Gilead and Galapagos are carrying out a number of studies to evaluate the potential of filgotinib in the treatment of a variety of inflammatory diseases, including the treatment of rheumatoid arthritis, Crohn's disease and ulcerative colitis in phase III Evaluation Pharma, a pharmaceutical market research organization, previously released a report predicting that filgitinib will become one of the key products of Geely to promote future growth, and the global sales volume is expected to reach 1.4 billion US dollars in 2024 However, in the field of JAK inhibitors, filgitinib will also face a number of competitors In addition to the two listed products Pfizer xeljanz and Lilly lumiant, the stronger competitors will be uPA acitinib of Aberdeen In particular, aberway used a $350 million priority review voucher to speed up uPA acitinib's review in the United States At present, upadacitinib has been successfully approved by the United States and the European Union for the treatment of moderate to severe rheumatoid arthritis (RA), with the brand name of rinvoq Evaluatepharma forecasts sales of $2.57 billion in 2024 after rinvoq goes public Source of the original text: Gilead and Eisai enter into agreement in Japan for the co promotion of the investigative rheumatoid arts therapy filgotinib, pending regulatory approval