Rheumatoid arthritis (RA) weight new drug! Rinvoq, an oral inhibitor of Jak1, has been approved by the European Union, with an annual sales volume of $2.6 billion

December 20, 2019 / bioun / -- abbvie, the US biopharmaceutical giant, recently announced that the European Commission (EC) has approved rinvoq (upadacitinib), a Jak1 inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have insufficient or intolerant response to one or more modified antirheumatic drugs (DMARD) Rinvoq is a daily selective and reversible JAK inhibitor, which can be used as a single drug therapy or combined with methotrexate (MTX) In the United States, rinvoq was approved by the FDA in mid August this year for the treatment of moderate to severe active rheumatoid arthritis (RA) adults with insufficient or intolerant response to methotrexate (mtx-ir) Currently, rinvoq is on the market in the United States It is not suitable for patients who have not received MTX treatment Rinvoq also marks the second Tim therapy approved by the US FDA this year It is worth mentioning that Albright accelerated rinvoq's review by using a priority review voucher (PRV), reducing the drug review cycle from the regular 10 months to 6 months "We are proud to offer this once-a-day tablet as a new treatment option for patients with moderate to severe rheumatoid arthritis," said Michael Severino, vice chairman and President of Aberdeen As a company dedicated to the discovery and delivery of transformative therapies for rheumatic patients in the past 20 years, rinvoq has expanded our portfolio of therapeutic options for rheumatic patients in Europe " Rinvoq has been approved in the United States and the European Union, both based on data from the Global Select III RA project The project is one of the largest registered phase III projects in the field of RA, including 5 phase III studies, involving more than 4400 RA patients These studies evaluated rinvoq's efficacy, safety, and tolerability in a wide range of RA patients, including those who failed or were intolerant to the use of biologically modified antirheumatic drugs, those who did not receive methotrexate (MTX), or those who did not respond adequately to MTX In all studies, rinvoq reached the primary and secondary end points of the study: as a single drug therapy and combined with traditional synthetic DMARD, it improved the symptoms and signs of RA, inhibited the progress of Radiology, and improved the body function In terms of safety, the most common serious adverse event was infection The top line data of these studies have been published before, and the main end point data are as follows: - select early study: in patients who have not received MTX, 52% of patients in rinvoq 15mg treatment group achieved acr50 remission in the 12th week of treatment, and 28% in MTX treatment group ——Select monotherapy study: in mtx-ir patients, at the 14th week of treatment, 68% of patients in rinvoq 15mg treatment group achieved ACR20 remission, and 41% of patients continued to receive MTX treatment ——Select compare study: in mtx-ir patients, 71% of the patients in rinvoq 15mg + MTX group achieved ACR20 remission in the 12th week, while 36% in placebo + MTX group ——Select-next study: it was carried out in patients with insufficient or intolerant response to traditional synthetic disease modified antirheumatic drugs (csdmard-ir) The treatment group was 12 weeks lower, and 64% of patients in rinvoq 15mg + csdmard treatment group achieved ACR20 remission, while 36% in placebo + csdmard treatment group ——Select beyond study: it was carried out in patients with inadequate or intolerant biological IR response At the 12th week of treatment, 65% of patients in rinvoq 15mg + csdmard treatment group achieved ACR20 remission, while 28% in placebo + csdmard treatment group Rinvoq's active drug ingredient is upadacitinib, an oral selective Jak1 inhibitor discovered and developed by Aberdeen, which is being developed to treat moderate to severe RA and other immune-mediated diseases Jak1 is a kinase that plays a key role in the pathophysiological process of various inflammatory diseases At present, the phase III clinical study of upadacitinib in the treatment of psoriatic arthritis (PSA), Crohn's disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), giant cell arteritis is in progress In addition, upadacitinib is also being evaluated for the treatment of ankylosing spondylitis The industry is very optimistic about rinvoq's business prospects According to a previous report released by evaluatepharma, a pharmaceutical market research organization, rinvoq's global sales will reach US $2.57 billion in 2024, making it the fifth largest selling anti rheumatic drug in the world Source: abbvie receives European Commission approval of rinvoq Gamma (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis