In Ionis Pharmaceuticals Inc.\u2019s second U.S. FDA approval in under a year, the agency approved Dawnzera (donidalorsen) as a prophylactic therapy in the rare and genetic disease hereditary angioedema (HAE). The approval came as scheduled as the NDA had a PDUFA date of Aug. 21. Dawnzera now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development.<\/p>\n
BioWorld<\/a> Regulatory<\/a> Dermatologic<\/a> Antisense<\/a> FDA<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"In Ionis Pharmaceuticals Inc.\u2019s second U.S. FDA approval in under a year, the agency approved Dawnzera (donidalorsen) as…\n","protected":false},"author":2,"featured_media":366661,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[3846],"tags":[47330,128388,128393,128394,128392,2460,46177,267,128390,128389,128391,6448,2444,70,16,15],"class_list":["post-366660","post","type-post","status-publish","format-standard","has-post-thumbnail","category-genetics","tag-antisense","tag-bioworld","tag-dawnzera","tag-dermatologic","tag-donidalorsen","tag-fda","tag-genetic-diseases","tag-genetics","tag-hereditary-angioedema","tag-ionis-pharmaceuticals-inc","tag-prophylactic-therapies","tag-rare-disease","tag-regulatory","tag-science","tag-uk","tag-united-kingdom"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115076884741713509","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/366660","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=366660"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/366660\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/366661"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=366660"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=366660"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=366660"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}