Novartis Receives FDA Complete Response Letter for SerelaxinBy
Novartis reports that FDA has issued a Complete Response Letter (CRL) regarding the bologics license application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure, stating that further evidence on the efficacy of RLX030 is required for a US license to be granted. RLX030,is a relaxin receptor agonist and is a recombinant form of a naturally occurring hormone (human relaxin 2)
“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 a company statement. “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 Phase III RELAX-AHF study. Novartis is continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with an global clinical program, including the RELAX-AHF-2 trial which will enroll over 6,300 patients.