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FDA Rejects Heart Failure Drug Serelaxin

Agency requests further efficacy data

The FDA has issued a complete response letter (CRL) regarding the biologics license application (BLA) for serelaxin (RLX030, Novartis) for the treatment of acute heart failure (AHF), stating that further evidence of the efficacy of serelaxin is required for a U.S. license to be granted.

The serelaxin submission included phase-II and phase-III efficacy and safety data, including findings from the pivotal phase III RELAX-AHF study. A global clinical program is continuing to supply data on the efficacy of serelaxin in AHF. This program includes the RELAX-AHF-2 trial, which will enroll more than 6,300 patients.

Serelaxin, a relaxin receptor agonist, is a recombinant form of a naturally occurring hormone (human relaxin 2) that is present in both men and women. Levels of this hormone rise in women during pregnancy to help the body cope with the additional cardiovascular demands. Serelaxin has multiple physiologic effects, including relaxing blood vessels and reducing fluid buildup. Evidence also suggests that the drug can reduce damage to the heart and vital organs, which may be important when considering the cascade of damage that occurs during AHF.

In June 2013, the FDA granted a “breakthrough therapy” designation to serelaxin for the treatment of patients with AHF. The agency’s decision was based on safety and efficacy results from the RELAX-AHF trial. This study also showed that patients who received serelaxin experienced a 37% reduction in mortality at 6 months after an AHF episode compared with patients who received conventional treatment.

In the RELAX-AHF study, serelaxin was shown to have both short- and longer-term effects, helping patients breathe during and after an AHF episode, thereby reducing the rate of heart failure worsening.

Sources: Novartis; May 16, 2014; and Novartis; June 21, 2013.

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