FDA advisory committee voted against approval of Novartis heart failure drug serelaxin
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Last Update: 2014-03-26
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Source: Internet
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Author: User
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Source: China Council for the promotion of drugs March 26, 2014 us time March 25, 2014, according to a briefing released on the website of the US drug agency, the FDA advisory committee voted against the approval of Novartis acute heart failure drug serelaxin "We do not recommend that seralaxin be approved at this time because there is not enough evidence to support its application for indications" to improve symptoms of acute heart failure by reducing the rate of deterioration of heart failure, "said reviewers Melanie blank, MD, and Tzu Yun McDowell Novartis confirmed its product positioning in a statement to Reuters, noting that seralaxin "has a good overall benefit risk assessment that confirms its significant clinical efficacy in patients with acute heart failure (AHF)." The results of the study submitted to FDA are based on a clinical study that showed a 37% reduction in mortality in seralaxin compared to the control group after six months of treatment However, FDA inspectors noted that the report data did not take cough, asphyxia, fatigue or anxiety into account as symptoms of acute heart failure "Therefore, the available evidence does not support its broad request for symptoms related to acute heart failure," the reviewer wrote The FDA plans to make a final decision on whether to approve Serelaxin on May 17th Original link: http://www.mmm-online.com/fda-panel-votes-no-on-novartis-heart-failure-drug/article/339722/
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