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…
As a veteran rheumatologist, I remember the clinical trials of etanercept’s (Enbrel’s) efficacy. And when the drug was first approved in 1998, I participated in those clinical trials and realized the effectiveness was astonishing. It was easy to tell which patients were treated with etanercept vs. those who received placebo, even though both groups were…
Any given rheumatology patient who needs a biologic disease-modifying anti-rheumatic drug (DMARD) will spend $22,000–44,000 on their medication each year…
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
Subcutaneous CT-P13 (Remsima SC), biosimilar to infliximab, will soon be available in the E.U. to treat adults with rheumatoid arthritis…
(Reuters)—The U.S. Food and Drug Administration on Friday approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade (infliximab), according to the regulator’s website. The biosimilar, Avsola (infliximab-axxq), has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders. The label for the…
Rituximab-abbs, which is biosimilar to rituximab, is now available in the U.S. to treat specific cancers…
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
Three clinical experts on gout offer their insights into common management errors, clinical pearls, new safety data from the FDA and the role of biologic therapies in the management of gout.
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…