FDA Awards Fast Track Designation for Cardiorentis’ Heart Failure Drug

The FDA has granted Cardiorentis AG fast track designation for Ularitide for acute decompensated heart failure.

A natriuretic peptide, Ularitide currently is in Phase 3 development with primary endpoints of assessing a patient's symptoms and persistent or worsening heart failure within the first 48 hours following treatment.

The company says it is expecting top-line results from its Phase 3 trial next spring, and plans to file an NDA with the FDA and a European Marketing Authorization Application in the second half of 2016.