Among the continued fourth-quarter filings was a new drug application submitted for CV Therapeutics Inc.'s Ranexa (ranolazine) for chronic angina, potentially the first in a new class of therapy for the condition in 20 years.
Backing the NDA are data from more than 3,300 patients and healthy volunteers, including 25,000 electrocardiograms, the company said. In all, the package consists of more than 300,000 pages in 1,100 volumes.
"The existing categories that are typically used are calcium channel blockers, nitrates and beta blockers," noted John Bluth, director of corporate communications for Palo Alto, Calif.-based CV Therapeutics. "They've been around for a while and they work well in many patients, but they all have some hemodynamic downsides, and we didn't see those in our clinical trials."
Ranexa, which is in the class of partial fatty acid oxidation inhibitors, lets the heart burn glucose rather than fat for energy, thus lowering its demand for oxygen without reducing heart rate, blood pressure or pumping ability in stable, or chronic, angina, which is the regular pain associated with heart disease.
"It's designed to help the heart work more efficiently with the limited oxygen that's available," Bluth said.
About 6.4 million people in the U.S. suffer chronic angina, with 400,000 more diagnosed every year and likely even more on the way. The U.S. Census Bureau predicts the 55-plus age group, which is most at risk for the condition, will increase by 80 percent over the next 30 years.
Ranexa might be preferred over other therapies in patients with congestive heart failure, chronic obstructive pulmonary disease or diabetes, Bluth said.
"You can certainly see distinct populations that are particularly attractive," he added, given the side effects shown by other treatments, such as depressive effects on blood pressure and heart rate. "It would be one of the tools available to physicians for angina patients."
Also in development is tecadenoson (CVT-510), an A1 adenosine receptor agonist for which CV Therapeutics recently offered positive Phase III data at the American Heart Association's Scientific Sessions in Chicago. Results showed the drug did better than expected in converting to normal an abnormally rapid heart rhythm. Encouraging data also have come from a Phase II study of CVT-3146, a selective A2A adenosine receptor agonist for use in cardiac perfusion imaging studies. (See BioWorld Today, Nov. 21, 2002.)
Ranexa is partnered with Innovex, a subsidiary of Quintiles Transnational, of Research Triangle Park, N.C., for sales and marketing, with CV Therapeutics gaining control of the sales force after five years.
CV Therapeutics' stock (NASDAQ:CVTX) closed Monday at $18.15, down 70 cents.