Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.
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.
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.
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.
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.