Cardiorentis AG, a privately held biopharmaceutical company, today announced that 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). 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. 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 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. "When patients with ADHF are admitted to the hospital, we have an opportunity and responsibility to not only alleviate their symptoms but to stabilize their clinical course," said Milton Packer, MD, principal investigator of the TRUE-AHF study. "For many decades, the focus has been on symptoms, but now we are developing ways of achieving and maintaining clinical stability, primarily by reducing the risk of worsening during the patient's hospital stay."
"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 co-primary endpoint is cardiovascular mortality.