In late October, the FDA approved the first biosimilar to ustekinumab to treat patients with psoriasis, psoriatic arthritis and other conditions. Ustekinumab-auub is expected to be available in the U.S. by 2025.
FDA Approves New Biosimilar for Adult & Pediatric Arthritis
This year, tocilizumab biosimilars have been approved to treat adult and pediatric patients with rheumatic disease, including rheumatoid arthritis, juvenile idiopathic arthritis and more, in both Europe and the U.S.
FDA Approves Canakinumab to Treat Gout Flares
Canakinumab has received FDA approval for the treatment of patients with acute gout flares.
FDA Accepts NDA for Investigational RA Agent
The FDA has accepted an investigational new drug application (NDA) for MYMD-1, an oral tumor necrosis factor-α inhibitor for patients with rheumatoid arthritis.
FDA Commissioner Charts Potential & Challenges of Emerging Technologies in Patient Care
Disparities, representativeness, algorithmic bias, the disruptive emergence of large language models and continued misinformation spread are key issues poised to transform patient care in American healthcare, FDA Commissioner Robert M. Califf, MD, said during a recent event.
FDA Issues Updated Prescribing Information for Opioids & Over-the-Counter Naloxone
New prescribing guidance has been issued by the FDA for immediate-release and extended-release/long-acting opioids for pain management. The agency also announced multiple label updates, which include changes to the Boxed Warnings.
FDA Approves Sarilumab for the Treatment of Adults with Glucocorticoid-Resistant PMR
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
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 Revokes Emergency Use Authorization for Evusheld
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.
First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles
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.
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