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