FDA accepts application for license for bioproducts to prevent migraines
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, theof theof theof food anddrugs
(the http:// http://) of the U.SFood andDrug(http:// has accepted an application for licensing of bioproducts (BLA) for migraine prevention, thehttp:// company of TheannouncedAbout eptinezumab
eptinezumab intravenously every 3 months The submission of the drug BLA is based on data from two Phase III studies of PROMISE 1 (NCT02559895) and PROMISE 2 (NCT02974153) The efficacy and safety of eptinezumab for the treatment of onset migraines (n?888) and chronic migraines (n-1072) were assessed, and the data showed that all major and critical secondary endpoints were reached studies, eptinezumab was similar in safety and tolerance to placebos eptinezumab is a human-derived IgG1 monoclonal antibody that targets binding calcitonin-related gene peptides (CGRP) CGRP is a neuropeptide that has been shown to be released during a migraine attack and may be a trigger for a migraine attack At present, CGRP has become a hot target for the development of migraine drugs In terms of medication
intravenous infusions are given every 3 months, Aimovig and Emgality are given once a month, and Ajovy is given once a month or every 3 months
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