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.
PHILADELPHIA—Officials from the U.S. Food & Drug Administration discussed recent drug approvals and drug safety issues at ACR Convergence in November in a session that captured the flurry of activity in the rheumatology sphere at the agency over the past year. Sabiha Khan, MD, clinical reviewer in the Division of Rheumatology and Transplant Medicine at…
PHILADELPHIA—The most vital component of avoiding drug shortages is early communication, officials from the U.S. Food & Drug Administration (FDA) said in a session at ACR Convergence 2022 in November. “Early notification is key in order to prevent and mitigate shortages,” said Hyun Son, PharmD, a member of the Drug Shortage Staff with the FDA…
Data from a small study show that severe methotrexate toxicity in patients who are 70 years of age and older and have rheumatic disease may be associated with poor renal function and the use of diuretic treatments.
A study from Amigues et al. found that bisphosphonate-associated osteonecrosis of the jaw is rare in patients with osteoporosis and may occur more often in patients treated with injectable zoledronic acid than in those treated with the oral bisphosphonates.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
Editor’s note: In November, the ACR honored Joel M. Kremer, MD, MACR, president of the Corrona Research Foundation, with its Distinguished Clinical Investigator Award for his outstanding contributions to the field of rheumatology as a clinical scientist (see story here). As the founder of the Consortium of Rheumatology Researchers of North America (CORRONA, now known…
How does a rheumatologist treat a pregnant woman when many medications are not approved for pregnancy or safety data are limited?