adds a couple interesting quotes:
CV Therapeutics Needs More Ranexa Studies, Panel Says (Update2)
2003-12-09 18:12 (New York)
CV Therapeutics Needs More Ranexa Studies, Panel Says (Update2)
(Adds CEO comment in 11th paragraph.)
Dec. 9 (Bloomberg) -- CV Therapeutics Inc., a biotechnology
company developing heart medicines, needs to conduct more studies
on its Ranexa drug before it can be used to treat chest pain, a
Food and Drug Administration advisory panel said.
The company is seeking approval to sell Ranexa for treating
angina, the pain caused when heart muscle is deprived of oxygen.
An FDA staff review released yesterday said more tests should be
done because of concerns over how Ranexa affects heart rhythms.
``A population resistant to available drugs wasn't
studied,'' said panel chairman Jeffrey Borer, a doctor at Weill
Medical College at Cornell University. ``So it is hard to know if
the drug would add benefit relative to risk.''
Approval of Ranexa would give the 13-year-old biotechnology
company its first product to sell. Analysts, who once predicted
annual sales of more than $200 million, say the company may have
to conduct several years of research to address FDA concerns.
The company needs to study the drug in patients who are
already getting the maximum treatment on existing medicines,
panelists said. People who don't respond well to those therapies
should be researched to better determine the benefit of Ranexa,
the panel said. The committee met to discuss deficiencies that
the FDA identified in an October letter to the company.
Panel members also recommended studies that include more
minorities and women. ``The primary problem was the range of
patients studied was relatively small,'' Borer said.
20 Years
Ranexa would be the first new kind of treatment for angina
introduced in the U.S. in more than 20 years. About 6.6 million
people in the U.S. experience the condition, the American Heart
Association estimates.
Episodes of the crushing pain in the chest, and sometimes
shoulders, neck and jaw, occur when the heart fails to get enough
oxygen through the bloodstream.
Trading in shares of Palo Alto, California-based CV
Therapeutics was halted for the panel's meeting. They slid $4.55,
or 27 percent, to $12.21 in Nasdaq Stock Market composite trading
yesterday when the FDA posted its staff review.
``I would be very concerned about its unrestricted use,''
said panel member Thomas Pickering, a heart doctor at Mount Sinai
Medical Center in New York. ``Potentially it does have a place in
patients who have failed'' to derive benefit from other
medicines, he said.
Discussing Options
CV Therapeutics Chief Executive Louis Lange said in an
interview the company would meet with the FDA to discuss its
options. He said he couldn't provide an estimate on how long new
trials might take.
Ranexa is part of a new class of drugs that would ease
angina by helping the heart use oxygen better. The drug appears
to work by altering the way in which the heart uses fatty acids,
one of its energy sources, the company has said. Research might
be required to rule out risks such as an effect on heart rhythm
and fertility, the FDA said.
People with angina are advised to stop smoking and make
changes in their diet, such as avoiding large meals. Many people
are treated with generic medicines such as nitroglycerin, which
dilates blood vessels, improving blood flow to the heart.
Because other angina drugs are available that don't carry
heart risks ``there needs to be a clear reason to approve a
therapy with what appears to be an additional, possibly life-
threatening risk,'' FDA division head Robert Temple said in an
October letter to the company.
The company's loss narrowed to $75.9 million, or $2.68 a
share, in the first nine months of this year, from $78.4 million,
or $3.04, a year earlier. |
