ORLANDO—Despite the COVID-19 pandemic, the past two years have been exciting for rheumatology providers and patients. We’ve seen the U.S. Food & Drug Administration (FDA) approve new therapies and expand indications for established drugs. At the 2022 ACR Education Exchange, Jeffrey Curtis, MD, MS, MPH, Marguerite Jones Harbert-Gene Ball Endowed professor of medicine, Division of…
Based on findings from a double-blind, placebo-controlled study evaluating its efficacy and safety, rituximab-arrx has received FDA approval for the treatment of patients with rheumatoid arthritis.
Two recent trials demonstrated the safety and efficacy of risankizumab-rzaa for the treatment of adults with active psoriatic arthritis.
The FDA has approved the use of secukinumab for pediatric patients with enthesitis-related arthritis and psoriatic arthritis, after research showed a longer time to disease flare than placebo.
On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
New concepts in autoimmunity & immunology are being discovered daily in research being conducted to understand the SARS-CoV-2 virus and its implications for rheumatology & all fields of medicine. Here are some insights shared by experts during day 1 of the Basic and Clinical Research Conference.
In early October, the FDA approved avacopan to treat anti-neutrophil cytoplasmic antibody associated vasculitis. Here are insights into the treatment’s risks and considerations.
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
The FDA has granted a seven-year marketing exclusivity for Octagam 10%, a 10% solution of a human intravenous immunoglobulin (IVIG) that treats adults with dermatomyositis.
ATLANTA—The ACR is actively engaged with the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for…