Drug to check cholesterol gets fda panel nod

1. Drug to check cholesterol
gets FDA panel nod
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2. Contd..
An expert committee that advises the Food and Drug Adminis tration
recommended on Wednesday that the agency approve the second in a new class of
drugs that can drive cholesterol levels down to unheard-of levels. Cardiologists
hope these new medicines will help prevent heart attacks for millions of
Americans, but the results of clinical trials that will definitively settle the ques ion
of the drugs' effectiveness will not be in until 2017.
The panel on Tuesday had advised the FDA to approve the first such drug,
alirocumab, made by Sanofi and Regeneron Pharmaceuticals, and on Wednesday
recommended approval for the second, a similar drug, evolocumab, made by
Amgen. The agency usually follows the advice of its expert committees.
Based on drastic reductions of so-called bad LDL cholesterol levels and the lack of
evidence so far of safety concerns, the panel decided that he drugs would fill a
critical unmet need for people at high risk of heart attacks who are unable to get
their cholesterol under sufficient control with statins, the mainstay drugs to ower
cholesterol that came on the market in the late 1980s.
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3. Contd..
Studies have consistently ound that elevated levels of LDL cholesterol
are a major risk factor for heart disease and that risk drops in lock step
with declines in LDL.
If the FDA approves the drugs, they are expected to change the
landscape for heart attack prevention and become blockbusters for the
companies that make them.
The panel unanimously agreed that Amgen's drug should be approved
for people with a rare genetic disorder, homozygous familial
hypercholesterolemia, because of their dire need for treatments. They
have LDL levels that can soar as high as five times the normal level and
they die young from heart attacks.
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4. Contd..
The panel voted 11 to 4 in favour of making the drug available to other
at-risk patients for whom statins don't work well.
School of meds for indigestion ups heart attack risk
A group of drugs commonly used to treat heartburn and indigestion
can raise the risk of heart attacks, new research has indicated. The
study of more than 2.9 million patients found that those who took
proton pump inhibitor (PPI) drugs, millions of which are prescribed in
the UK every year, were between 16%-21 % more likely to suffer a
heart attack. PPIs, which are only recommended for shortterm use, are
often prescribed by doctors but some can also be bought overthe-
counter.
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