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Amgen gets conditional approval for Prolia in China

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Amgen gets conditional approval for Prolia in China

Amgen Inc.'s Prolia was conditionally approved by China's National Medical Products Administration to treat a certain type of bone tumor.

The drug will be used for patients with giant cell tumor of bone, or GCTB, who cannot be treated by surgery. GCTB is a rare tumor affecting the bones. It is usually benign but can cause symptoms including joint pain, swelling and limited mobility.

As part of the approval, the Thousand Oaks, Calif.-based company is required to continue clinical trials for the drug in China and draw up a comprehensive plan to manage risks. Adverse effects of Prolia, or denosumab, include serious infections.

Prolia, which works by inhibiting tumor cell growth, was listed as urgently demanded for import by Chinese regulators in 2018, which accelerated its approval process.

The European Commission and U.S. Food and Drug Administration approved the expanded use of Prolia in May for treating osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy in men and women at high risk of fracture in 2018.