Print“Novartis says it is conducting a second pivotal global clinical trial that will enroll over 6,300 patients with results expected in 2016. ”
Novartis said that the U.S. Food and Drug Administration did not approve its biologics license application to market RLX030, also known as serelaxin, for the treatment of acute heart failure, stating that it needed further evidence on its efficacy before it would grant a license to market the drug in the United States.
The decision came as no surprise. Though Serelaxin had received the agency’s Breakthrough Therapy designation, which guaranteed it would have a speedy review, an FDA advisory panel voted unanimously in March against approving the drug. The advisory panel expressed serious concerns over the design of its 1,161 patient pivotal trial and said Novartis failed to confirm the drug’s effect on shortness of breath and the rate of heart failure. The European Medicines Agency also rejected Novartis’ marketing application, telling the drugmaker in January that it had failed to demonstrate significant benefit and expressing concern “about the way the effectiveness of the medicine in the study had been analyzed.”
The RLX030 submission to the FDA included mid- and late-stage efficacy and safety data from the clinical development program. Novartis says it is conducting a second pivotal global clinical trial that will enroll over 6,300 patients with results expected in 2016. The pharma intends to resubmit the New Drug Application with the additional data when it becomes available.
“We continue to believe RLX030 has the potential to be an important treatment for acute heart failure and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing,” says Tim Wright, global head of development at Novartis.
RLX030, a relaxin receptor agonist, is a recombinant form of a naturally occurring hormone present in both men and women that rises in women during pregnancy to help the body cope with the additional cardiovascular demands. RLX030 has multiple effects including relaxing the blood vessels and reducing fluid buildup. There is also some evidence to suggest it can reduce damage to the heart and vital organs.
May 16, 2014
http://www.burrillreport.com/article-fda_rejects_novartis%e2%80%99_serelaxin_for_acute_heart_failure.html
