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Astellas and Amgen Astellas' Evenity (romosozumab) Receives MHLW Approval for Patients with Osteoporosis at High Risk of Fracture in Japan

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Astellas and Amgen Astellas' Evenity (romosozumab) Receives MHLW Approval for Patients with Osteoporosis at High Risk of Fracture in Japan

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  •  The approval from Japanese Ministry of Health is based on two P-III study FRAME &  BRIDGE assessing Evenity (210mg) vs PBO in 7-180 & 245 postmenopausal women with osteoporosis & men with osteoporosis respectively for 12 months
  • Evenity (romosozumab) 105mg IV SC is a mAb- indicated for the reduction of    osteoporosis at high risk of fracture in adults- with its MAA filling under review by the US FDA and EMA
  • Amgen Astellas’ Evenity has received its first approval worldwide and third for the    company. In 2004- Amgen and UCB collaborated to jointly develop Evenity worldwide

Ref: Amgen Astellas BioPharma| Image: Astellas


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