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Evenity Approval History

FDA Approved: Yes (First approved April 9, 2019)
Brand name: Evenity
Generic name: romosozumab-aqqg
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Development History and FDA Approval Process for Evenity

Apr  9, 2019Approval FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
Jan 21, 2019Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
Jul 12, 2018Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA
Sep 11, 2017Evenity (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine
Jul 16, 2017Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA
May 21, 2017Amgen and UCB Announce Top-Line Phase 3 Data from Active-Comparator Study of Evenity (Romosozumab) in Postmenopausal Women with Osteoporosis
Apr  1, 2017Amgen And UCB Report New Data At ENDO 2017 Examining The Option Of A Second Course Of Treatment With Evenity (romosozumab)
Nov 12, 2016Results From Phase 3 BRIDGE Study Show Romosozumab Significantly Increases Bone Mineral Density In Men With Osteoporosis
Sep 26, 2016Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
Sep 18, 2016Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis
Jul 21, 2016Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA
Mar 20, 2016Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis
Feb 21, 2016Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis
Oct 12, 2015New Exploratory Analysis Showed Romosozumab Increased Estimated Bone Strength More Than Teriparatide
Sep  1, 2015Amgen And UCB Announce Positive Top-Line Results From Open-Label Phase 3 Study Of Romosozumab Compared With Teriparatide

Further information

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