Amgen Canada’s EVENITY (romosozumab) Receives Health Canada Approval to Treat Osteoporosis in Postmenopausal Women at High Risk for Fracture

Amgen Reports In-Favor Uphold of its Two Patents for Repatha from Delaware Jury

Shots:

  • The approval of EVENITY is based on two P-III study results FRAME and ARCH. FRAME and ARCH involved assessing of EVENITY (210 mg) vs PBO and EVENITY (210 mg) followed by 12 months of alendronate treatment (70 mg) vs alendronate monothx in 7,180 and 4,093 postmenopausal women with osteoporosis and previous fracture history respectively
  • The FRAME study resulted in reduction of new vertebral (spine) fractures at 12 months compared to PBO while ARCH reported reduction in the risk of clinical fracture after a median follow-up of 33 months
  • EVENITY is a mAb designed to inhibit the activity of sclerostin further resulting in increased bone formation and to a lesser extent decreased bone loss. The EVENITY development program consists of 19 clinical studies enrolling 14,000 patients globally

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