Amgen scores priority review for chronic heart failure drug
- Amgen's ivabradine is approved in the EU for the treatment of stable angina and chronic heart failure( CHF). It is marketed under the brand name Procorolan.
- Amgen licensed ivabradine from Servier as part of a cross-licensing agreement that the two companies signed off on last year.
- The priority review status was granted based on data from a phase III trial involving 6,500 patients.
Amgen has data from a phase III trial that compares the current standard of care, including beta blockers, in addition to a placebo and ivabradine in order to evaluate their respective effects on heart function. In patients who were in sinus rhythm with reduced left ventricular function and a heart rate less than 70 beats per minute, ivabradine effectively adjusted the implicated current in the sinoatrial node without any adverse effects.
The prevalence of CHF is increasing in the US. Currently, there are 5.1 million individuals affected by the condition.
- Pharma Times Amgen heart failure drug gets FDA priority review