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Romosozumab, sold under the brand name Evenity (/ ɪ ˈ v ɛ n ɪ t i / ih-VENN-ih-tee or with the pin-pen merger, / ɪ ˈ v ɪ n ɪ t i / ih-VINN-ih-tee), is a medication used to treat osteoporosis. [ 7 ] [ 8 ] It has been found to decrease the risk of fractures of the spine .
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2019: In January, Evenity (romosozumab) received approval in Japan, [76] [77] followed by FDA approval in April. [78] In June, Kanjinti (trastuzumab-anns) was approved by the FDA. [79] Amgen announced it would acquire Nuevolution AB for 1.61 billion Swedish crowns ($166.8 million) to enhance its drug discovery capabilities. [80]
The FDA approved Samsung Bioepis Co., Ltd.'s Renflexis (infliximab-abda) in April 2017. [1] Biogen released another biosimilar, Flixabi, which was approved in Germany, the UK, and the Netherlands. [62] Flixabi was approved for use in the European Union in May 2016. [5] In December 2017, Ixifi (infliximab-qbtx) was approved in the United States. [4]
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The CHMP provides an unfavorable feedback to Amgen's (AMGN) marketing application for Evenity to treat severe osteoporosis in postmenopausal women with risk of fracture.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The FDA reviewed 25 cases between July 2010 through May 2021 during the investigation. ... approved in 2010 to treat bone loss in postmenopausal women and later approved to treat men and women at ...