Amgen gets fast-track designation from FDA for heart drug ivabradine

THOUSAND OAKS, Calif.—On April 18, California biotech Amgen announced that the U.S. Food and Drug Administration (FDA) had granted its Fast Track designation for the investigational drug ivabradine for patients with chronic heart failure.

But, while this designation may be new, and the drug candidate itself relatively “new” for Amgen, ivabradine has been in use quite a while already in Europe. Developed by French pharmaceutical company Servier, ivabradine—under the brand name Procoralan—was approved by the European Medicines Agency in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure in patients with elevated heart rates.

In August 2013, Amgen announced that it had in-licensed ivabradine to gain commercial rights in the United States for the drug, as well as obtaining an exclusive option to develop and commercialize Servier’s investigational molecule, S38844—at the time in Phase 2 study for the treatment of heart failure—for cardiovascular diseases in the United States. At the same time, Servier obtained rights to commercialize omecamtiv mecarbil in Europe, a compound being tested for potential applications in the treatment of heart failure in patients with systolic dysfunction.

Although the two companies didn’t disclose the complete financial terms of their deal at the time, they did note that Amgen was making a one-time $50 million upfront payment in addition to future milestone and royalty payments for ivabradine.

Ivabradine is an oral drug that inhibits the I_f current (also known as the “funny” current) in the sinoatrial node, the body’s cardiac pacemaker.

“Amgen is pleased to enter into this collaboration with Servier to bring potential new cardiovascular treatment options to patients in both the U.S. and Europe,” said Dr. Sean E. Harper, executive vice president of research and development at Amgen, at the time of the licensing deal last year. “A critical unmet medical need remains for patients who don’t respond adequately to current available therapies for heart failure and angina. Ivabradine, an I_f inhibitor, offers a novel alternative approach for patients with elevated heart rates. We value Servier’s extensive experience in cardiovascular disease and look forward to working with them as Amgen continues to build our presence in this area.”

“Ivabradine is a first-in-class innovative drug for the treatment of heart failure and angina. The clinical benefit and safety profile are supported by the results of clinical studies performed or being performed in more than 40,000 patients,” said Dr. Emmanuel Canet, head of research and development at Servier, at the same time. “I strongly believe that Servier’s expertise in heart failure will complement Amgen’s efforts in making omecamtiv mecarbil, a very innovative and complementary approach to treating heart failure, available to patients in Europe.”

The FDA Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation allows for such options as eligibility for priority review, if relevant criteria are met, more frequent meetings with FDA, and rolling review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. The BLA or NDA review otherwise usually does not begin until the drug company has submitted the entire application to the FDA.

Amgen plans to file for FDA approval of ivabradine in the second quarter of this year.

As noted by Amgen in announcing the Fast Track designation, about 26 million people have heart failure worldwide, including approximately 5.1 million people in the United States. Projections show that by 2030, the prevalence of heart failure will increase 25 percent from 2013 estimates and, despite currently available treatments, prognosis is poor.