Novartis heart failure drug sinks at Phase 3 trials

pharmafile | March 22, 2017 | News story | Research and Development Acute heart failure, Novartis, serelaxin 

Novartis’ serelaxin was once thought to be the major hope for its cardiovascular pipeline – analysts projected it to become a blockbuster and Novartis thought it could shore up gaps in its portfolio from patent expires on drugs such as Diovan. It was one of the first drugs to receive the FDA’s then newly introduce ‘breakthrough therapy’ designation. Now, it looks like that promising future for the drug may be in tatters, as it failed to impress in a Phase 3 trial to add to its previous failures to take-off.

Novartis released that it had not meet either of its primary endpoints in the RELAX-AHF-2 study to determine whether serelaxin could reduce cardiovascular death or worsening heart failure in patients with acute heart failure (AHF).

The treatment was added to standard therapy for AHF and included 6,600 patients, in a trial begun in October 2013. The length of the trial and number of patients involved indicate how much hope Novartis had for the drug.

The warning signs were there from early in the development of serelaxin, with rejections by the FDA and the EMA in 2014 due to the lack of displayed efficacy. Clearly, the issues with efficacy were not resolved with the longer trial and it will be back to the drawing board for Novartis on this particular drug.

“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,” said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “We will continue to further analyse the data to better understand and learn from these results as well as evaluate next steps for the overall program. Novartis would like to thank the patients, investigators, and site personnel around the world for their unwavering support of this study. We remain committed to improving and extending the lives of patients with cardiovascular disease and will continue to invest in ways to improve their outcomes.” 

The results are disappointing for sufferers of AHF, which is particularly dangerous to those over the age of 65. After hospitalisation, one in five patients do not survive a full year and becomes increasing dangerous the more AHF events occur.

Ben Hargreaves

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