FDA approves Amgen’s heart failure drug
pharmafile | April 16, 2015 | News story | Sales and Marketing | Amgen, Corlanor, FDA, NICE, Vectibix, heart, ivabradine
Amgen has earned sign-off from the FDA for Corlanor as a treatment for people with worsening heart failure symptoms.
Corlanor (ivabradine) is now approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms that are stable and who are also taking beta blockers at the highest dose they can tolerate.
The nod is Amgen’s first for a cardiovascular drug in the US. Corlanor is already available in the EU, and is recommended by NICE for heart failure in people who have already had four weeks of treatment with standard therapies. The FDA decision comes just days after the EU regulator, the EMA, approved Amgen’s cancer drug Vectibix, in combination with chemotherapy, for metastatic colorectal cancer.
Corlanor was reviewed under the FDA’s priority programme and granted fast-track designation to speed the process further. The decision was based on the results of a Phase III SHIFT trial in 6,500 people, which found Corlanor kept people with heart failure out of hospital for longer than a placebo.
In the US it is estimated that heart failure affects approximately 5.7 million people, and projections show that by 2030, the prevalence of heart failure will increase 46%, to 8.3 million.
“Heart failure is a leading cause of death and disability in adults,” says Dr Norman Stockbridge, director of the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research. “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.”
“We are excited to introduce Corlanor, the first new chronic heart failure medicine approved by the FDA in nearly a decade, for patients who are at a significantly greater risk of hospitalisation due to worsening heart failure in the US,” adds Sean Harper, who is executive vice president of R&D at Amgen.
“Many heart failure patients are repeatedly admitted to the hospital, which can cause a great burden on the patient and on healthcare resources. We hope that today’s approval of Corlanor as an innovative therapeutic option will address a major unmet need for patients, their families and the healthcare system.”
Lilian Anekwe
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