Drugs in the Pipeline Analysis

Generic Drug
Name (Brand)
Drug Company
Route Indication(s) Regulatory
Priority review * Status
Therapeutic Considerations
Affected
Population
Estimated
Peak Sales
Estimated
Cost/day
olmesartan/
amlodipine
besylate
(Azor )
Daiichi
Oral
For the treatment
of hypertension
NDA submitted:
11/2006
Estimated
approval date:
9/2007
Daiichi Sankyo submitted an NDA for a
fixed-dose combination of its angiotensin
receptor blocker Benicar (olmesartan)
and the calcium channel blocker
amlodipine besylate (Norvasc). The
combination therapy may be used alone
or with other antihypertensive drugs.
The firm is targeting a launch of the
fixed-dose combination in fall 2007,
shortly after approval.
In a phase III trial of 1940 patients with
mild to severe hypertension, amlodipine
(5 mg – 10 mg)/olmesartan (10 mg – 40
mg) reduced seated systolic blood
pressure an average of 30.1mmHg and
seated diastolic blood pressure an
average of 19.0mmHg. This was in
comparison to mean reductions of
19.7mmHg and 12.7mmHg for systolic
and diastolic blood pressure,
respectively, in those patients treated
with amlodipine alone. Amlodipine/
olmesartan was well tolerated with a
similar adverse event profile to either
component alone.
According to
recent estimates,
nearly one in three
U.S. adults has
high blood
pressure, but
because there are
no symptoms,
nearly one-third of
these people don't
know they have it.
According to the
American Heart
Association, many
people have high
blood pressure for
years without
knowing it.
Uncontrolled high
blood pressure
can lead to stroke,
heart attack, heart
failure or kidney
failure. This is why
high blood
pressure is often
called the "silent
killer."
NA
$2 - $3 per
day
Updated 8/2007
Copyright © 2007 Medco Health Solutions, Inc.
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