Swiss pharmaceutical firm Novartis has failed to secure approval from the US Food and Drug Administration (FDA) for RLX030 (serelaxin), a relaxin receptor agonist, as a treatment for patients with acute heart failure (AHF).
Currently, the FDA has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for serelaxin, stating that further evidence on its efficacy is required.
Novartis Pharmaceuticals global head of development Tim Wright said the company continues 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.
"In accordance with the FDA’s advice, we will continue to expedite our clinical trial programme to build the supporting body of evidence," Wright said.
The submission for the drug was based on Phase II and III efficacy and safety data from the clinical development programme, including the major Phase III RELAX-AHF trial.
In order to expand the data supporting the efficacy of the drug in acute heart failure, the company is currently carrying out a second late-stage RELAX-AHF-2 trial, which will enrol more than 6,300 patients.
The company intends to resubmit the new drug application (NDA) for RLX030 with additional data when available.
RLX030 is a recombinant form of a naturally occurring hormone present in both men and women, which rises in women during pregnancy to help the body cope with the additional cardiovascular demands.
It has multiple effects including relaxing the blood vessels and reducing fluid buildup and some evidence also suggests that 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.
Image: FDA has issued a CRL regarding the biologics licence application (BLA) for Novartis’s acute heart failure drugserelaxin. Photo: courtesy of cooldesign/freedigitalphotos.net.
