Palo Alto-based CV Therapeutics won U.S. approval to promote its only marketed drug, Ranexa, as an initial treatment for chronic chest pain, broadening the potential use.
The Food and Drug Administration also endorsed Ranexa’s benefits in preventing irregular heart rhythms called atrial fibrillation and bradycardia and in improving blood-sugar control in patients with diabetes, the company said Thursday in a statement. Ranexa was initially cleared as a second-choice treatment for the recurring chest pain called chronic angina in 2006.
CV Therapeutics conducted a post-approval study to allay regulators’ concerns that Ranexa may alter the heart’s electrical cycle then sought changes to the prescribing information so it could promote wider use. The company was surprised to receive all the revisions it sought to the label, Chief Executive Louis Lange said Thursday in a phone interview.
“It’s more than we dreamed,” Lange said. “We never really expected bradycardia or atrial fibrillation to be in there. They’re not home runs —it’s a grand slam.”
CV Therapeutics rose 9 cents to $9.79 in Nasdaq trading.
Ranexa sales may rise more than tenfold to $700 million a year with the expanded approval, Lange said. The company is adding 40 sales representatives in the U.S. Northeast to promote the product to primary-care physicians, expanding the target market beyond specialized cardiologists, he said.
George Zavoico, an analyst at Cantor Fitzgerald, estimated earlier this year that sales would reach almost $500 million by 2010 if the FDA removed prescribing restrictions and endorsed new statements about the drug’s benefits.
Findings from the CV Therapeutics’ study published last year showed the drug’s effects on the heart weren’t harmful, as regulators had feared: Ranexa improved blood flow to the heart and reduced the risk that patients would develop an erratic heart rate.
Because it doesn’t lower blood pressure or reduce the heart rate as nitrate-based treatments do, patients on Ranexa can also take impotence drugs, the company said Thursday.
