Novartis Receives CRL For Heart Failure Drug RLX030

Novartis announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection to its Biologics License Application (BLA) for RLX030 (serelaxin).

According to the company, the CRL stated that more evidence on the drug’s efficacy is needed for a U.S. license. The BLA submission to the FDA for RLX030 was supported by Phase 2 and 3 efficacy and safety trial data under the company’s clinical development program. The pivotal Phase 3 RELAX-AHF study was also used as a basis for the application.

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

RLX030 is a relaxin receptor agonist and a recombinant form of human relaxin 2. Human relaxin 2 is a naturally occurring hormone in both men and women but is observed in increased levels in pregnant women. The hormone is thought to help the body cope with the increased cardiovascular demands brought about by pregnancy. The drug induces relaxation of the blood vessels and reduction of fluid buildup. Evidence also suggests that the drug can reduce damage to the heart and vital organs, a benefit which may be of particular significance when considering the damage that occurs during an acute heart failure episode. Heart failure affects more than 20 million people around the world.

Novartis said that it is continuing to expand data supporting RLX030’s efficacy in AHF with ongoing global clinical programs. The company said it plans to conduct an additional trial labeled RELAX-AHF-2, which is expected to enroll over 6,300 patients for RLX030.