Cardiorentis' Ularitide Received FDA Fast Track Designation For The Treatment Of Acute Decompensated Heart Failure

Cardiorentis AG, a privately held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) 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.”

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.

Heart failure occurs when the heart loses its ability to pump blood efficiently through the body and vital organs. It is a growing problem worldwide, affecting  more than 26 million people worldwide. In 2011, there were nearly 3 million hospital admissions with heart failure as the primary diagnosis in countries across the globe. It is a life-threatening condition, which requires immediate medical attention. Signs and symptoms of ADHF include extreme fatigue and shortness of breath, worsening kidney function, severe swelling, sudden weight gain and a distended jugular vein along the side of the neck. The American Heart Association estimated the total cost of this chronic disease approached $39.2 billion in 2010.

Fast Track is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication can help resolve questions and issues quickly, often leading to earlier drug approval and patient access to important new therapies. Fast Track designated products are eligible for accelerated approval and priority review, if relevant criteria are met, and rolling FDA review of marketing applications.