FDA Speeds Ivabradine Review

The US Food and Drug Administration (FDA) announced it will give priority review status to Amgen’s application to market ivabradine as a treatment for chronic heart failure.

The drug works to slow the heart rate in appropriate patients without causing negative effects on cardiac rhythms. It was developed by Les Laboratoires Servier in Suresnes, France, and first approved by the European Medicines Agency (EMA) as Procoralan in 2005. According to Servier, a global pharmaceutical firm, Procoralan (also sold as Corlentor) is available in 102 countries.

Amgen said it is elated by the FDA’s decision.

“The priority review designation by the FDA is evidence that chronic heart failure is a serious condition which leads to high rates of rehospitalization and poor prognosis despite available treatments,” Sean Harper, MD, executive vice president of Research and Development at Amgen said in a statement.

There are an estimated 5.1 million patients in the US with chronic heart failure, according to Amgen. The prevalence of the disease is expected to increase by 25% by 2030, due in part to the aging population. About half of U.S. patients with the ailment die within five years of diagnosis, the company said.

The FDA in April, 2014, gave Amgen’s new drug approval application for ivabradine fast track status on the basis that it could potentially treat a life-threatening condition. The FDA grants priority review designation to “applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions,” according to information on the FDA’s website.

In the United Kingdom, the National Health Service (NHS) in a 2012 statement noted that while the drug costs about £1.40 a day ($2.32), that is more than beta-blocker drugs, which cost “just a few pounds a month.” But a year later the NHS added the drug to its list of recommended treatments for patients with chronic stable angina and for certain heart failure patients. The starting dosage is 5 mg twice daily, the NHS said.

The EMA on Aug. 5, 2014, announced it had started an in-depth review of how effective the drug has been for patients, following up on preliminary results of an earlier study conducted by Servier.

That research, a project known as SIGNIFY (a name taken from “study assessing the morbidity- mortality benefits of the If inhibitor ivabradine in patients with coronary artery disease”) showed “a small significant increase in the combined risk of cardiovascular death and myocardial infarction with ivabradine in a subgroup of patients with chronic stable angina,” Servier has said.

Amgen has the rights to sell and market ivabradine in the US through a collaboration with Servier.