How was Ranolazine approved?

Ranolazine is an anti-anginal medication. It works by improving blood flow to help the heart work more efficiently. It is used to treat chronic angina (chest pain). But it is not for use during an acute (emergency) attack of angina. It may also be used for purposes not listed in this medication guide.

Ranolazine(CAS NO:94-62-2), sold under the trade name Ranexa by Gilead Sciences (who acquired the developer, CV Therapeutics in 2009), is an antianginal medication. In India, it is sold under the name "Ranozex". On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris.

In this article , let us learn about how Ranolazine(CAS NO:94-62-2) was approved to use in Europe and United States.

In Europe

On 24 April 2008, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Latixa, 375-mg, 500-mg and 750-mg, prolonged-release tablets intended for treatment of patients with stable angina pectoris. The applicant for this medicinal product is CV Therapeutics Europe Limited. 

The approved indication is: “Latixa is indicated 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 (such as beta blockers and/or calcium antagonists).”

In United States

The Food and Drug Administration has approved a new, first-line indication for ranolazine(CAS NO:94-62-2) for the treatment of chronic angina. The new labeling also provides information showing ranolazine 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 Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.

According to the revised labeling, ranolazine is indicated for the treatment of chronic angina and may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and common cardioprotective treatments for cardiovascular disease, such as antiplatelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers.

Ranolazine may now be used as part of a medical therapy regimen for chronic angina patients, regardless of whether or not they receive a stent or other medical intervention. Ranolazine does not reduce heart rate or blood pressure and, unlike long-acting nitrates, ranolazine can be prescribed for patients taking oral erectile dysfunction treatments.

These new labeling changes were supported by a supplemental new drug application submitted in September 2007 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.

The revised labeling includes new language noting a significantly lower incidence of arrhythmias (ventricular tachycardia, bradycardia, supraventricular tachycardia and new atrial fibrillation) in patients treated with Ranexa versus placebo. This difference in arrhythmias did not lead to a reduction in mortality, a reduction in arrhythmia hospitalization or a reduction in arrhythmia symptoms.

The revised labeling also includes new language noting ranolazine produces small reductions in HbA1c. Though Ranolazine should not be considered a treatment for diabetes, it may be a particularly useful medication for the reduction of chronic angina in this patient population, which is difficult to treat because some antianginal medications, such as beta blockers, increase HbA1c.


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