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

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

Click here to read full press release/ article | Ref: Amgen Astellas BioPharma| Image: Twitter