Ranexa is a new molecular entity and the first drug the agency has approved to treat chronic angina, typified by chest pain, in over a decade, the FDA said.
However, in studies, the drug appeared less effective in women than in men, the agency noted.
The FDA said the new drug affects the electrical conduction in the heart and should only be taken by patients who have not responded to other anti-anginal drugs, like long-acting nitrates, calcium channel blockers and beta blockers.
Ranexa was studied in the ERICA (Efficacy of Ranolazine in Chronic Angina) and CARISA (Combination Assessment of Ranolazine In Stable Angina) trials. The ERICA study enrolled 565 patients who were experiencing about 4.5 angina attacks per week while taking a full dose of a calcium channel blocker, but after receiving Ranexa, the attacks decreased to about 1 attack per week, compared to placebo.
In CARISA, 823 patients on either a calcium channel blocker or beta blocker were randomized to receive either Ranexa or placebo and followed for 12 weeks using a formal exercise treadmill test.
The study showed that patients in the Ranexa group had a mean exercise improvement similar to that seen with other anti-anginal therapies.
Symptoms of chronic angina include chest pain, pressure, or discomfort that occur during exercise because the heart muscle is not getting enough oxygen, FDA said. The most common cause of chronic angina -- diagnosed in about 6.8 million Americans each year -- is coronary heart disease, where the coronary arteries become blocked with plaque deposits.