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Articles tagged with "FDA approval"

FDA Approves Sarilumab for the Treatment of Adults with Glucocorticoid-Resistant PMR

Michele B. Kaufman, PharmD, BCGP  |  March 14, 2023

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.

FDA Approves Abaloparatide to Treat Men with Osteoporosis & a High Risk of Fracture

Michele B. Kaufman, PharmD, BCGP  |  February 15, 2023

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.

FDA Approves Ustekinumab for Children with PsA

Michele B. Kaufman, PharmD, BCGP  |  November 7, 2022

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 Promising for Children with Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  October 6, 2022

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.

FDA Approves Riabni, a Rituxumab Biosimilar, to Treat Patients with RA

Michele B. Kaufman, PharmD, BCGP  |  July 13, 2022

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.

FDA Approves Risankizumab-rzaa for PsA

Michele B. Kaufman, PharmD, BCGP  |  April 20, 2022

Two recent trials demonstrated the safety and efficacy of risankizumab-rzaa for the treatment of adults with active psoriatic arthritis.

FDA Approves Secukinumab for Children with Enthesitis-Related Arthritis & PsA

Michele B. Kaufman, PharmD, BCGP  |  February 2, 2022

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.

Considerations for Prescribing Avacopan for ANCA-Associated Vasculitis

Michele B. Kaufman, PharmD, BCGP  |  October 27, 2021

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.

FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira

U.S. Food & Drug Administration  |  October 19, 2021

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…

FDA Grants Octapharma 7-Year Market Exclusivity for Octagam 10%

Michele B. Kaufman, PharmD, BCGP  |  September 15, 2021

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.

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