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Novartis heart failure drug fails to meet primary endpoints in Phase III trials.

M2 EQUITYBITES-March 22, 2017-Novartis heart failure drug fails to meet primary endpoints in Phase III trials


The results from Novartis' (VTX: NOVN) global Phase III RELAX-AHF-2 study reveal it did not meet the primary endpoints, the company announced on Wednesday.

The primary endpoints of the study, which was investigating the efficacy, safety and tolerability of RLX030 (serelaxin) in patients with acute heart failure (AHF), were reduction in cardiovascular death through day 180 and reduced worsening heart failure through day five when added to standard therapy in patients with AHF.

The trial began in October 2013 and involved 6,600 patients. Serelaxin was added to standard therapy for AHF.

Analysts believed the treatment would become a blockbuster and provide a much-needed treatment for AHF sufferers. Serelaxin was one of the first drugs to receive the 'breakthrough therapy' designation from the US Food and Drug Administration (FDA).

Global head of drug development and chief medical officer at Novartis, Vas Narasimhan, said: "We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition.

"We will continue to further analyse the data to better understand and learn from these results as well as evaluate our next steps for the overall programme."

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Publication:M2 EquityBites (EQB)
Date:Mar 22, 2017
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