A committee of an EU agency has recommended that the marketing authorization of the medicine Tavneos be revoked in the European Union because its benefits are no longer proven to outweigh its risks.<\/p>\n
Tavneos, or avacopan, was developed in the United States to treat rare intractable diseases that involve inflammation of the blood vessels.<\/p>\n
The human medicines committee of the European Medicines Agency had been reviewing the drug to assess new information that raised questions over data integrity of the main study supporting the medicine’s marketing authorization in the EU.<\/p>\n
The committee recommended on Friday that existing patients be switched to suitable alternatives.<\/p>\n
The European Commission, the executive body of the EU, will discuss whether to revoke authorization of the drug in the EU.<\/p>\n
The medicine is also used in Japan. Nagano Prefecture-based Kissei Pharmaceutical, which sells the product in Japan, says Tavneos was likely administered to roughly 8,500 patients in the year through January.<\/p>\n
There are reports that 20 died after taking the drug, due to severe liver dysfunction, including cases for which causal links are unknown.<\/p>\n
The company has called on medical institutions and others to exercise great caution when administering the drug. It says following the committee’s recommendation, it is discussing with the health ministry and other authorities what actions it should take in response.<\/p>\n","protected":false},"excerpt":{"rendered":"A committee of an EU agency has recommended that the marketing authorization of the medicine Tavneos be revoked…\n","protected":false},"author":2,"featured_media":560390,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[274],"tags":[2786,36586,18,135,19,17,386,36588,462,5,36587,36591,36592,36593,36590,31899,36589,36594,753,65],"class_list":["post-560389","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-asia","tag-biz","tag-eire","tag-health","tag-ie","tag-ireland","tag-japan","tag-japan-broadcasting-corporation","tag-medication","tag-news","tag-nhk","tag-nhk-world","tag-nhk-world-premium","tag-nhk-world-tv","tag-nhkworld","tag-nuclear","tag-public-broadcaster","tag-radio-japan","tag-tech","tag-world"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/116835047564197734","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/560389","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=560389"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/560389\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/560390"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=560389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=560389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=560389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}