New chest pain drug set for March launch, co. says
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CV Therapeutics Inc. Chief Executive Officer Louis Lange said on Thursday that the company’s recently approved drug for chest pain is on track to be in 30,000 pharmacies by the end of March.
Palo Alto, California-based CV Therapeutics last month received U.S. Food and Drug Administration approval of Ranexa for treatment of chronic angina, the chest pain caused by an insufficient supply of oxygen to the heart.
Lange said the company’s 250-person sales force plans to begin marketing the drug at a major meeting of cardiologists next month in Atlanta and shipments will start shortly thereafter.
“We expect to be in 30,000 retail outlets by the end of March,” the CEO said.
Ranexa, which directs the heart to burn sugar for energy instead of fat, works without dropping blood pressure, which is a common side effect of other angina treatments.
The FDA approved Ranexa for patients who have not achieved adequate response with other anti-anginal drugs, and said it should be used in combination with other treatments, such as beta-blockers or nitrates.
About 25 percent of the estimated 6.4 million Americans with chronic angina have become resistant to existing drugs.
The new drug option “is going to be a big deal for patients and their doctors,” Lange said “Patients will know very quickly if this is working and how well.”
The company is conducting another trial of Ranexa in patients with acute coronary syndrome (ACS), which occurs when a plaque inside an artery ruptures and blocks blood flow to the heart muscle.
This trial, results from which are expected late this year or early next year, provides “two ways for CV Therapeutics to win,” Lange explained.
Ranexa’s approval in chronic angina had been delayed for years over safety concerns, including indications that it prolonged the “QT interval” - the time it takes the heart to electrically recharge itself.
Safety data from the ACS trial may put those concerns to rest, opening the way to expanding Ranexa’s label to include first-line treatment of all patients with chronic angina, the CEO said.
In addition, if the trial’s primary goal is met, CV Therapeutics would be able for file with the FDA for approval of Ranexa as a treatment for ACS, which affects 1.2 million Americans.
“This drug has got a lot of value embedded in it. It represents a strategic change in the way cardiac patients will be treated,” Lange said.
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