AbbVie Inc. has submitted applications for its rheumatoid arthritis drug upadacitinib to both the U.S. Food and Drug Administration and the European Medicines Agency.
The applications contain data from a late-stage study, called Select, comparing upadacitinib with methotrexate, a widely used medication for rheumatoid arthritis. Patients with AbbVie's drug showed greater improvement in health-related quality of life.
The drug is a JAK1-selective inhibitor that reduces inflammation. It is also being tested in late-stage trials to treat psoriatic arthritis, Crohn's disease, atopic dermatitis and ulcerative colitis, as well as ankylosing spondylitis in an earlier-stage study.
As the company's Humira — the best-selling drug in the world in 2017 and also a rheumatoid arthritis treatment — is threatened by biosimilar competition and other similar drugs on the market, AbbVie's next foray into the space was highlighted as an important followup on the earnings call for the third quarter.
Upadacitinib is expected to launch in 2019 pending approval from the regulatory agencies, according to executives on the call in November.