FDA accepts new drug application for AbbVie JAK1 inhibitor upadacitinib for treatment of adult patients with rheumatoid arthritis

recently, AbbVie announced that the U.SFood andDrug(http://Administration (
FDA(http://) has accepted the
new drug(http://application (NDA) for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) by JAK1 inhibitor upadacitinib.com."This time, AbbVie used a Priority Review Voucher (PRV) to speed up the review of upadacitinib NDA, which reduced the review period from the regular 10 months to six monthsAbbVie expects to receive FDA review sq.ein the third quarter of 2019The EuropeanMedicines(http://Authority (EMA) is also reviewing the listing of adult patients with moderate and severe RA in upadacitinib treatment (MAA)Upadacitinib's NDA and MAA are based on data from the global SELECT PHASE III RA projectThe project includes 5 Phase III studies (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426) with more than 4000 patients with moderate to severe RAin all studies, upadacitinib reached the primary and secondary endpoints of the studyThe most common severe adverse event is infectionTop line data for these studies has been published beforeAbout upadacinib
upadacitinib is an experimental oral selective JAK1 inhibitor discovered and developed by AbbVie and is being developed to treat moderate to severe RA and other immuno-mediated diseasesJAK1 is a kinase that plays a key role in the pathophysiological process of a variety of inflammatory diseases, Phase III clinical studies on upadacitinib for psoriasis arthritis (PsA), Crohn's disease (CD), acursion dermatitis (AD), and ulcerative colitis (UC) are currently under wayIn addition, upadacitinib is also being evaluated for treatment of syllano syllitis