ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…
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FDA Rheumatology Update: New Drug Approvals, Plus Expanded Drug Indications & Safety Concerns
Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Update on the Management of Takayasu Arteritis
A rare form of large vessel vasculitis, Takayasu arteritis persents with no clear patterns, with patients experiencing vascular symptoms, as well as such systemic symptoms as fever and weight loss. A systematic literature review found evidence to guide rheumatologists in monitoring and treating their patients with Takayasu arteritis…
Year in Review: Rheumatic Disease Research in 2019
ATLANTA—Encouraging data on interleukin (IL) 23/IL-17 pathway drugs in psoriatic arthritis (PsA), JAK inhibitors in rheumatoid arthritis (RA) treatment and new evidence on physical activity and bone health in women were among the highlights of the 2019 ACR/ARP Annual Meeting’s Clinical Year in Review. Susan Manzi, MD, MPH, director of the Lupus Center for Excellence…
New Options for Treatment-Resistant RA
Two JAK inhibitors, one recently approved by the FDA, have shown improvements in patients with active RA for whom other therapies have proved ineffective…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
GI Disease in Early Systemic Sclerosis Associated with Worse Outcomes
In patients with systemic sclerosis (SSc), gastrointestinal disease may be associated with lower quality of life and increased risk of death. Research showed that SSc patients with severe GI disease had markers of muscle inflammation, skin fibrosis and vasculopathy…
AbbVie’s RA Drug Succeeds in Late Stage Study
(Reuters)—Abbvie Inc. says its experimental drug met the main goal of halting progression of moderate to severe rheumatoid arthritis (RA) in a late-stage trial. The drug, upadacitinib, was tested as a monotherapy in patients who have not been treated with chemotherapy agent methotrexate. Upadacitinib, which belongs to a class of drugs known as JAK inhibitors,…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…
AbbVie’s Rheumatoid Arthritis Drug Succeeds in Late-Stage Trial
(Reuters)—U.S. drugmaker AbbVie Inc said on Wednesday late-stage data showed its rheumatoid arthritis drug performed better than a placebo in reducing symptoms in moderate-to-severe patients who have not adequately responded to standard treatments. Two doses of the drug, upadacitinib, induced a statistically significant reduction in symptoms compared to a placebo in the 12-week long study,…
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