Amgen and UCB’s Evenity (Romosozumab) Receive CHMP Positive Opinion to Treat Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

Amgen and UCB’s Evenity (Romosozumab) Receive CHMP Positive Opinion to Treat Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Evenity (romosozumab) based on P-III global studies including FRAME, ARCH and BRIDGE studies assessing Evenity vs PBO and active comparator in ~11,000 postmenopausal women with osteoporosis at high risk of fracture and with no history of MI or stroke
  • The CHMP’s recommendation will be reviewed by EC to approve therapy in Europe with its anticipated decision by the year-end 2019  
  • Evenity is a bone-forming mAb, act by inhibiting the activity of sclerostin thus resulted in increased bone formation and to a lesser extent decreased bone resorption and is an approved therapy in the US & Japan, South Korea for the treatment  of osteoporosis in women & women and men at high risk for fracture respectively

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