April 17th, 2014
FDA Grants Fast Track Status to Ivabradine
Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an unmet medical need, will aid the development and speed the review of the drug.
The company said it planned to file for FDA approval in the second half of this year. The drug has been marketed for several years in Europe by Servier under the brand name of Procoralan. Amgen has licensed the drug for commercial use in the U.S.
Ivabradine slows the rate of the heart by inhibiting the so-called “funny” current within the sinoatrial node. The main basis for Amgen’s application will be the SHIFT trial, published in the Lancet in 2010. In that trial, 6558 patients with heart failure and a heart rate > 70 bpm were randomized to ivabradine or placebo. After a median 22 months of followup, the rate of cardiovascular death or hospital admission for worsening heart failure was 24% in the ivabradine group and 29% in the placebo group (HR 0.82, 95% CI 0.75–0.90, p<0.0001). The SHIFT investigators concluded that the beneficial effect of ivabradine was due to its heart-rate lowering effect.
However, in an accompanying comment, John Teerlink was critical of the trial, noting that many patients had not received optimal medical therapy, especially high dose beta blockers. “Whether ivabradine can improve outcomes in addition to optimally managed heart failure therapies or its benefits relative to other therapies, especially beta blockers, remains unknown,” he wrote.