{"id":43299,"date":"2014-05-16T15:03:25","date_gmt":"2014-05-16T19:03:25","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=43299"},"modified":"2014-05-16T15:03:25","modified_gmt":"2014-05-16T19:03:25","slug":"fda-turns-back-novel-drug-for-acute-heart-failure","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/05\/16\/fda-turns-back-novel-drug-for-acute-heart-failure\/","title":{"rendered":"FDA Turns Back Novel Drug for Acute Heart Failure"},"content":{"rendered":"<p>Novartis\u00a0<a href=\"http:\/\/www.novartis.com\/newsroom\/media-releases\/en\/2014\/1786125.shtml\">said<\/a>\u00a0today that the FDA had issued a complete response letter for the biologics license application for\u00a0RLX030. The drug, also known as serelaxin,\u00a0is\u00a0a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy.<\/p>\n<p>The FDA decision was not unexpected since earlier this year its Cardiovascular and Renal Drugs Advisory Committee\u00a0<a title=\"FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-advisory-panel-recommends-against-approval-of-novartis-heart-failure-drug\/\">voted unanimously against approval<\/a>. The rejection occurred despite the fact that the drug\u00a0<a title=\"Novel Heart Failure Drug from Novartis Gains \u2018Breakthrough Therapy\u2019 Designation from FDA\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/novel-heart-failure-drug-from-novartis-gains-breakthrough-therapy-designation-from-fda\/\">received a\u00a0\u201dbreakthrough therapy\u201d\u00a0designation<\/a>\u00a0from the FDA last year. Serelaxin was also\u00a0<a title=\"European Setback for Novel Heart Failure Drug\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/european-setback-for-novel-heart-failure-drug\/\">turned down for approval in\u00a0Europe<\/a>\u00a0earlier this year.<\/p>\n<p>Novartis\u00a0said it plans to continue development of the drug.\u00a0&#8220;We continue to believe RLX030 has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing,&#8221; said a company executive. &#8220;In accordance with the FDA&#8217;s advice we will continue to expedite our clinical trial program to build the supporting body of evidence.&#8221;<\/p>\n<p>The BLA relied heavily on data from the\u00a0<a href=\"http:\/\/www.forbes.com\/sites\/larryhusten\/2012\/11\/06\/relax-ahf-stirs-interest-in-novel-drug-for-acute-heart-failure\/\">the pivotal phase III RELAX-AHF study<\/a>. Novartis said it was &#8220;continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with an extensive global clinical program, including the RELAX-AHF-2 trial which will enroll over 6,300 patients.&#8221;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis\u00a0said\u00a0today that the FDA had issued a complete response letter for the biologics license application for\u00a0RLX030. The drug, also known as serelaxin,\u00a0is\u00a0a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. The FDA decision was not unexpected since earlier [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[549,196,1475],"class_list":["post-43299","post","type-post","status-publish","format-standard","hentry","category-heart-failure","tag-acute-heart-failure","tag-fda","tag-serelaxin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43299","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=43299"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43299\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=43299"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=43299"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=43299"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}