New rheumatoid arthritis drug! Gilead oral Jak1 inhibitor filgotinib applied for listing in the United States, priority review coupon accelerated review!

December 20, 2019 / BIOON / -- Gilead Sciences recently announced that it has submitted a new drug application (NDA) to the U.S Food and Drug Administration (FDA) to approve the oral selective Jak1 inhibitor filgotinib for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) It is worth mentioning that there is also a priority review voucher (PRV) submitted with NDA, which can shorten the expected review time As part of the terms of the partnership, the NDA submission triggered a $20 million milestone payment from Gilead to partner Galapagos The NDA is also the third filiotinib filing to regulators in the past five months, following applications to the European Drug Administration (EMA) and the Ministry of health, labor and welfare (MHLW) earlier this year This NDA is based on 52 weeks of data from the global phase III finance 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 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 "The NDA submission of filgotinib is an important step in bringing potential new treatment options to the RA patient population," said merdad parsey, MD, gild's chief medical officer In clinical trials, filgutinib has been proved to be effective and tolerable, which can significantly improve the RA treatment response of patients with this chronic debilitating disease Filgutinib is a highly selective Jak1 inhibitor 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 Original source: Gilead submissions filgtotinib new drug application to U.S Food and drug administration under priority review for rheumatoid arts treatment