CV Therapeutics' Ranexa Reduces Erratic Heart Rates (Update1)
2007-09-05 16:25 (New York)
(Adds closing shares in sixth paragraph, analyst in 10th.)
By Michelle Fay Cortez
Sept. 5 (Bloomberg) -- CV Therapeutics Inc.'s Ranexa, used
to treat chronic chest pain, also reduces the risk that patients
will develop an abnormally fast heart rate, a company-funded
study found.
The data, presented at the European Society of Cardiology
meeting and published in the journal Circulation, should ease
concerns about Ranexa's safety, researchers said. The product is
now approved by the U.S. Food and Drug Administration for use
only after standard treatment has failed because early studies
suggested Ranexa may alter the heart's electrical cycle.
The study used continuous monitoring to track the cardiac
rhythms of more than 6,000 patients after they were given Ranexa,
known chemically as ranolazine, or a placebo after a heart attack
or acute chest pain. Ranexa significantly reduced episodes of
fast and slow heart rates, known as arrhythmias, in each group of
patients studied, including those at highest risk.
The results ``provide important and reassuring data
regarding the long-term safety of ranolazine,'' said Benjamin
Scirica, the lead researcher and a cardiologist at Brigham and
Women's Hospital in Boston. ``Studies specifically designed to
evaluate the potential role of ranolazine as an anti-arrhythmic
agent are warranted.''
Previously presented data from the same study found Ranexa
didn't reduce death or subsequent heart attacks, the primary goal
of the study. The researchers included monitoring to gather more
details on the intravenous drug's safety.
CV Therapeutics, based in Palo Alto, California, rose 3
cents to $9.55 at 4 p.m. in Nasdaq Stock Market trading. They
have fallen 22 percent since March 6 when the drug's failure to
cut deaths and subsequent heart attacks was first announced.
No Increase in Deaths
Ranexa didn't increase sudden deaths from cardiovascular
complications, the study found. The reduction seen in atrial
fibrillation, when the heart quivers and beats ineffectively,
wasn't statistically significant.
``There is absolutely no question'' the drug reduces
arrhythmias and it should be approved as an initial treatment for
chronic chest pain known as angina, Chief Executive Officer Louis
G. Lange said in a telephone interview.
The company plans to ask the U.S. Food and Drug
Administration to approve broader use of Ranexa and remove a
warning on its label about the possible heart risks by the end of
next month, officials said. The current label limits sales, which
were $15.3 million in the second quarter.
More Comfortable Prescribing
``Although we do not expect an immediately noticeable impact
on prescription totals, we think the paper will amplify CV
Therapeutics' sales force message to doctors that they should
feel comfortable prescribing Ranexa for more than their most
difficult-to-control angina patients,'' wrote David Webber, an
analyst at First Albany Corp. in New York, in a note to
investors.
Ultimately, the company may pursue an additional approval
for treating patients with erratic heart rhythms, for which there
are few safe treatments, he said.
``We're excited about the properties and looking at future
anti-arrhythmic opportunities,'' Lange said. ``The anti-
arrhythmia properties are terrific news for patients and give
doctors another way to look at the drug.''
--Editor: Hallam (mfe/jto)
To contact the reporter on this story:
Michelle Fay Cortez in Minneapolis at +1-952-475-6840 or
mcortez@bloomberg.net |
