FDA issues Complete Response Letter for RLX030 for acute heart failure

Novartis announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 is required for a US license to be granted.

“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,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “In accordance with the FDA’s advice we will continue to expedite our clinical trial program to build the supporting body of evidence.”

The RLX030 submission to the FDA included phase II and III efficacy and safety data from the clinical development program, including the pivotal phase III RELAX-AHF study. Novartis is 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.

About RLX030

RLX030, a relaxin receptor agonist¹, is a recombinant form of a naturally occurring hormone (human relaxin 2) present in both men and women which rises in women during pregnancy to help the body cope with the additional cardiovascular demands^2,3. RLX030 has multiple effects including relaxing the blood vessels and reducing fluid buildup. Some evidence also suggests it can reduce damage to heart and vital organs, which may be of particular importance when considering the cascade of damage that occurs during an AHF episode^4,5,6.

References

1. Du X-J, Bathgate RAD, Samuel CS, Dart AM, Summers RJ. Cardiovascular effects of relaxin: from basic service to clinical therapy. Nat. Rev. Cardiol. 2010;7:48-58.
2. Teichman SL, Unemori E, Dschietzig, T, et al. Relaxin, a pleiotropic vasodilator for the treatment of heart failure. Heart Fail Rev. 2009;14:321-329.
3. Teichman SL, Unemori E, Teerlink JR, Cotter G, Metra M. Relaxin: Review of biology and potential role in treating heart failure. Curr Heart Fail Rep. 2010;7:75-82.
4. Teerlink JR, Cotter G, Felker GM, et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet. 2013;381:29-39.
5. Metra M, Cotter G, Davison BA, et al. Effect of Serelaxin on Cardiac, Renal, and Hepatic Biomarkers in the Relaxin in Acute Heart Failure (RELAX-AHF) Development Program. J Am Coll Cardiol. 2013;61:196-206.
6. Gheorghiade M, Pang PS. Acute Heart Failure Syndromes. J Am Coll Cardiol. 2009;53:557-73.