Sandoz Receives FDA Approval for Wyost, Jubbonti

By Chris Wack

Sandoz said that U.S. Food and Drug Administration approved Wyost and Jubbonti the first denosumab biosimilars to treat skeletal-related events and osteoporosis.

Wyost is approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Jubbonti is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

The FDA approval is based on clinical studies and accompanied by labeling with safety warnings.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 05, 2024 13:56 ET (18:56 GMT)

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