FDA Advisory Committee Votes Against Novartis' Serelaxin For Heart Failure

Novartis announced in a press release that Food and Drug Administration (FDA) panelists voted 11-0 against RLX030 (serelaxin). The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) reviewed data from RLX030 clinical trials for the treatment of acute heart failure (AHF). The FDA is not bound to follow the Advisory Committee’s recommendations, however a denial seems likely. Committee chair A. Michael Lincoff, MD said, "I think it's clear the drug does have an effect on worsening heart failure but given the limitations of how that was not rigorously defined, we don't know how much of the effect is on minor heart failure changes versus major.”

Novartis believes that with over one million people experiencing AHF and a resultant downward spiral of poorer health, RLX030 could be an important medicine. The company has consulted with the FDA on the next steps in moving RLX030 towards approval. Tim Wright, Global Head of Development of Novartis Pharmaceuticals said, "The discussion provided important information that we will address with the FDA as it completes its review. In the meantime we'll continue to drive our robust clinical trial program and build upon the already established body of evidence."

Acute Heart Failure

Acute heart failure (AHF) occurs when the heart is suddenly not able to pump blood. Causes of heart failure include birth defects, disease, or bad habits like lack of exercise. Diabetes, high blood pressure, infections, allergic reactions, and other conditions can lead to AHF. Symptoms include arm or leg pain, nausea, weakness, and shortness of breath, the most common symptom. About five million people in the U.S. suffer with chronic and acute heart failure and the prognosis worsens with each episode as organs become damaged, decreasing survival chances.

RLX030

RLX030 (serelaxin) is a relaxin receptor agonist. The agent is recombined from human relaxin 2 hormone, present in a natural form in both men and women. In women, the hormone increases during pregnancy to help the mother cope with cardiovascular demands. RLX030 works to reduce fluid buildup, relax blood vessels, and possibly reduce damage to internal organs.

The FDA granted RLX030 a Breakthrough Therapy (BT) designation status in June of 2013. The RELAX-AHF-2 clinical trials are underway including over 5,000 patients worldwide and 1,000 in the U.S. Study results are due in 2016. At the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting, panelists considered data from phase II and III trials. Members of the committee did not see enough evidence to support approval but left the door open for further trials and evidence to review.