Cardiorentis’ Ularitide Receives FDA Fast Track Designation04.01.2016 08:27
The U.S. Food and Drug Administration (FDA) has granted Fast Track status to Ularitide, an investigational therapy for the treatment of acute decompensated heart failure (ADHF). Cardiorentis anticipates top-line results from the TRUE-AHF Phase III trial in Spring 2016 and expects to file a U.S New Drug Application (NDA) and European Marketing Authorization Application (MAA) in the second half of 2016.
The FDA’s Fast Track process is intended to facilitate the development and expedite the review of drugs for the treatment of serious conditions addressing an unmet medical need. The treatment of ADHF has remained the same for decades, with poor short term and long term prognoses for patients that are significantly worse than for many types of cancer.
“We are pleased that the FDA continues to acknowledge the current high unmet need for patients with ADHF by granting Fast Track status for Ularitide,” said Johannes Holzmeister, M.D., CEO of Cardiorentis. “We look forward to working closely with the FDA on an expedited review process for Ularitide, as we are eager to provide a potential new treatment option for patients suffering from ADHF.”
Ularitide is a natriuretic peptide in Phase III development for the treatment of ADHF. The trial has fully enrolled 2,157 patients in over 200 centers across the U.S., Europe, Canada and Latin America. TRUE-AHF is a randomized, double-blind, placebo-controlled event driven trial with two co-primary endpoints. The first is a composite endpoint for ADHF, which assesses a patient’s symptoms and persistent or worsening heart failure within the first 48 hours after initiation of treatment. The second coprimary endpoint is cardiovascular mortality.
Founded in 2010, Cardiorentis is a private biopharmaceutical company headquartered in Zug, Switzerland. The company is committed to bringing novel therapies to the treatment of heart failure and related cardiovascular diseases. Cardiorentis’ disease-based technology platform integrates expertise in protein biology to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs.