Biotech major Amgen (Nasdaq: AMGN) on April 9 announced it had received US Food and Drug Administration approval for its osteoporosis treatment Evenity (romosozumab), nearly three months after the Japan approval.
“We filed the Evenity NDA around the same time as we filed it in the US and other markets. Japan became the first country to have Evenity approved, which is a significant milestone,” James Cai, Amgen vice president of global regulatory affairs for Japan and Asia, told the Pharma Letter’s local correspondent Wang Fangqing.
Evenity, co-developed by Amgen and Belgian drugmaker UCB (Euronext: UCB), was brought into Japan by the Tokyo-based joint venture between Amgen and Astellas (TYO: 4503).
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