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news.CV Therapeutics has received marketing authorization from the European Medicines Agency for ranolazine for the treatment of patients with chronic angina in all 27 EU member states.
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This approval follows a positive opinion from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use.
CV Therapeutics’s Ranolazine is approved for use in Europe as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies. Ranolazine is approved for use in 375mg, 500mg and 750mg doses, administered twice daily.
The approved European labeling reflects data from the Merlin Timi-36 and other recently reported studies, including data showing statistically significant reductions in ventricular arrhythmias with ranolazine.
The labeling also notes that the ability of ranolazine to reduce cellular calcium overload is expected to improve myocardial relaxation and decrease left ventricular diastolic stiffness.
Louis Lange, chairman and CEO of CV Therapeutics, said: “We expect ranolazine could be available to patients and physicians across Europe beginning in the first part of 2009, as we continue to see very strong interest from potential commercial partners.”