The US Food and Drug Administration has approved a new, first line indication for CV Therapeutics anti-angina drug Ranexa (ranolazine).
Initially approved in the US in February 2006, Ranexa was the first new class of anti-anginal therapy in the US to be approved in more than 20 years.
The new indication will see the drug, which was approved as an add-on therapy for patients who were inadequately controlled or intolerant to first line anti-anginal treatments, now being used as a treatment for chronic angina.
The drug may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and other cardio-protective treatments.
“This important FDA action allows the benefits of Ranexa to be extended to more patients. The new labelling clearly describes the substantial proven safety and efficacy of Ranexa for the treatment of chronic angina,” said Louis Lange, CV Therapeutics Chairman and Chief Executive.
The new labelling also shows that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and bradycardia. The label also states the drug reduces haemoglobin A1c in patients with diabetes.
The labelling changes were supported by a supplemental new drug application submitted in September last year that included data from the 6,560 patient MERLIN-TIMI 36 trial, which showed no adverse trend in death or arrhythmia in a high risk acute coronary syndromes patient population.
