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