Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal Women at High Risk for Fracture

 Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal Women at High Risk for Fracture

Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal Women at High Risk for Fracture

Shots:

  • The FDA’s approval is based on two P-III FRAME & ARCH studies result assessing Evenity (210mg) vs PBO & alendronate (70mg) in 7,180 & 4,093 postmenopausal women with osteoporosis respectively
  • The P-III FRAME & ARCH study results: @12mos. and 24mos. significant reduction in vertebral (spine) fracture; @33 mos. reduction in risk of clinical fracture; increment in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck @12mos.
  • Evenity (romosozumab-aqqg) is a mAb, inhibits sclerostin resulting in an increment of bone formation and decreases in bone resorption and is collaboratory developed by Amgen and UCB. Evenity also has a boxed warning in its label as it increases the risk for MI, stroke, & cardiovascular death

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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