Evenity Approval Status
- FDA approved: No
- Brand name: Evenity
- Generic name: romosozumab
- Company: Amgen Inc.
- Treatment for: Osteoporosis
Evenity (romosozumab) is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Development Status and FDA Approval Process for Evenity
|Sep 11, 2017||Evenity (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine|
|Jul 16, 2017||Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA|
|May 21, 2017||Amgen and UCB Announce Top-Line Phase 3 Data from Active-Comparator Study of Evenity (Romosozumab) in Postmenopausal Women with Osteoporosis|
|Apr 1, 2017||Amgen And UCB Report New Data At ENDO 2017 Examining The Option Of A Second Course Of Treatment With Evenity (romosozumab)|
|Nov 12, 2016||Results From Phase 3 BRIDGE Study Show Romosozumab Significantly Increases Bone Mineral Density In Men With Osteoporosis|
|Sep 26, 2016||Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab|
|Sep 18, 2016||Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis|
|Jul 21, 2016||Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA|
|Mar 20, 2016||Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis|
|Feb 21, 2016||Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis|
|Oct 12, 2015||New Exploratory Analysis Showed Romosozumab Increased Estimated Bone Strength More Than Teriparatide|
|Sep 1, 2015||Amgen And UCB Announce Positive Top-Line Results From Open-Label Phase 3 Study Of Romosozumab Compared With Teriparatide|
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