Amgen (AMGN), Servier Heart Drug Runs Into Safety Concerns In Major Clinical Study
9/3/2014 6:31:01 AM
September 3, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
The SIGNIFY study, released on Aug. 31 at the European Society of Cardiology Congress and published in the New England Journal of Medicine, showed that ivabradine was not beneficial in patients with stable coronary artery disease without clinical heart failure (CHF). Researchers found that the drug did not decrease the risk of a major cardiac episode in patients with the condition.
Les Laboratoires Servier developed the drug, and the U.S. Food and Drug Administration granted priority review designation for ivabradine for the treatment of chronic heart failure.
There was a negative result in a sub-group of 12,000 patients in the SIGNIFY study, according to Reuters. Additionally, approximately 7.6 percent of patients suffered an adverse event, compared to just 6.5 percent of those who were given a placebo. Further research is being done to determine the effects of ivabradine, but commentary in the New England Journal of Medicine advised doctors to exercise caution when prescribing the drug to patients.
Ivabradine has been marketed under the name Procoralan since being approved by the European Medicines Agency in 2005. It has been prescribed to those with stable angina, which is defined as chest pain and discomfort stemming from coronary heart disease. The drug was eventually approved for the treatment of CHF in 2012.
Now, the European Medicines Agency can decide to maintain, amend, suspend or withdraw its approval of ivabradine stemming from this new information.
The drug had received fast-track designation from the FDA back in April. However, negative reviews of the drug that come from the European Medicines Agency may hurt the reputation of ivabradine.
Amgen has submitted a New Drug Application to the FDA that is based on global clinical trial data from the Phase 3 SHIFT study.
Ivabradine is typically administered to patients orally, and it is thought to help reduce an individual’s heart rate without impacting the heart’s contractility.
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