November 7, 2008
CV Therapeutics’s Ranexa Wins FDA Approval for First Line Antianginal Use
CV Therapeutics, a biopharmaceutical company, has announced that the FDA has approved a new, first line indication for Ranexa for the treatment of chronic angina.
The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.
According to the revised labeling, Ranexa may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and common cardio-protective treatments for cardiovascular disease such as anti-platelet therapy, lipid-lowering therapy, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.
Ranexa may now be used as part of an optimal medical therapy regimen for chronic angina patients, regardless of whether or not they receive a stent or other medical intervention. Ranexa does not reduce heart rate or blood pressure and, unlike long acting nitrates, Ranexa can be prescribed for patients taking oral erectile dysfunction treatments, the company said.
These significant new labeling changes were supported by a supplemental new drug application submitted previously that included data from the 6,560 patient Merlin-Timi 36 trial. The revised labeling includes new language noting that there was a significantly lower incidence of arrhythmias in patients treated with Ranexa versus placebo.
Louis Lange, chairman and CEO of CV Therapeutics, said: "This important FDA action allows the benefits of Ranexa to be extended to more patients. The new labeling clearly describes the substantial proven safety and efficacy of Ranexa for the treatment of chronic angina, the debilitating cardiac chest pain that affects more than nine million Americans each year."