In late December, the FDA approved subcutaneous abaloparatide for the treatment of men with osteoporosis at a high risk of fracture. This approval is based on a placebo-controlled study that showed abaloparatide led to significant increases in bone mineral density of the lumbar spine, total hip and femoral neck. Abaloparatide was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
The Food & Drug Administration announced Jan. 26 that tixagevimab/cilgavimab (Evusheld) is no longer authorized for use in the U.S. The decision was based on new data suggesting that the treatment is unlikely to be active against the most common current SARS-CoV-2 variants.
After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
After examining study data from pediatric patients with both psoriasis and psoriatic arthritis (PsA), the FDA approved ustekinumab as a treatment for patients aged 6–17 years old with PsA.
Belimumab is now FDA approved to treat children aged 5 years and older with active lupus nephritis, providing treatment options for pediatric patients at risk of developing renal damage.
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.