Fda panel backs new drug to fight heart attacks

1. FDA panel backs new drug to
fight heart attacks
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2. Contd..
An expert group recommended on Tuesday that the Food and Drug Administration
approve a powerful new drug to protect against heart attacks. If approved, it would
be the first in a major new class of medicines in a generation that significantly
lower levels of cholesterol, the leading cause of heart disease. Dr. Joshua W.
Knowles, a Stanford cardiologist, called the medicines “a triumph of the modern
genetic revolution.“ The idea for such drugs arose from genetic studies about a
decade ago and has tantalized cardiologists ever since.
Early results of clinical trials raised hopes that the therapies would be critical new
additions to the treatment arsenal for those at risk of heart disease, the biggest
killer of Americans.
People who have taken them have seen their LDL cholesterol, the so-called bad
cholesterol, plunge to remarkably low levels. But definitive evidence of the drugs'
effectiveness in reducing heart attacks and deaths will come only after large clinical
trials are completed in 2017.
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3. Contd..
The panel, in a 13 to 3 vote, recommended the approval of Sanofi and
Regeneration Pharmaceuticals' drug, alirocumab. On Wednesday , the
committee will turn to Amgen's drug, evolocumab.
The FDA usually follows the recommendations of its advisory panels, but not
always. The agency says that if it approves the drugs based on their effects
on cholesterol, the approval will not be rescinded even if trials now
underway fail to show the drugs reduce the risk of heart attacks and deaths.
Once a drug is approved doctors can prescribe it to patients other than those
for whom it was intended, although insurers generally will not pay .
The drugs are injected ev ery two weeks or once a month, depending on the
formulation.
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4. Contd..
The companies are asking that they be approved for use in three groups: patients with high
levels of LDL cholesterol who cannot lower it enough with statins, the mainstay drug for
cholesterol lowering first introduced in the late 1980s; people at very high risk because
they have already had a heart attack or have diabetes and cannot get their levels low
enough with statins; and people with high levels of LDL who cannot tolerate statins.
Doctors often aim for LDL levels of 70 for people at high risk.
The problem for the expert group was to decide if there was enough evidence to approve
the Sanofi drug without waiting for results from the large clinical trials.
Those who voted no said drugs should not be approved until clinical trials established their
efficacy , and voiced the worry that people participating in the trials would drop out once
the drugs were approved so they could be sure to get the medicine, not a placebo.
“We need clinical outcomes,“ said Dr. Peter Wilson of Emory University .
Some on the panel felt comfortable recommending approval only for a narrow group of
people with a genetic condition, heterozygousfamilial hypercholesterolemia, who cannot
control their cholesterol with statins alone.
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