Home » FDA Awards Fast Track Designation for Cardiorentis’ Heart Failure Drug
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.
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