The world's
fastest growing prescription
medicine for the safe and
effective treatment of
seasonal allergy symptoms was
launched today in
Japan, the second largest allergy
medication market in the world.
Allegra®
(fexofenadine hydrochloride) was approved for use by
the Japanese Ministry of Health on September 22,
2000, and is now available by prescription only.
Allegra is a non-sedating antihistamine that has been
shown in
clinical trials and in clinical practice to safely
provide relief from symptoms associated with seasonal
allergies, in as little as one hour after
dosing. Allegra
was approved in Japan with recommended
dosing of
one 60 mg tablet, twice daily.
"Allegra has become one of the most widely used
antihistamines in the world today, and will become an
important new treatment option for millions of people
in Japan who are seeking safe, non-sedating relief
from disruptive and uncomfortable allergy symptoms,"
said Richard Markham, Chief Executive Officer of
Aventis Pharma, the company that discovered,
developed and markets Allegra.
Reports estimate that as much as USD $1. billion
(source: IMS, MAT August 2000) is spent each year in
Japan on allergy medications. It is also estimated that
Japan represents 20% of the overall global allergy
market, and is second only to the United States in the
use of antihistamine treatments.
"We believe the Japanese market represents a
considerable opportunity for Allegra and we are
pleased that allergy sufferers there now have this
option," said Mr. Markham.
Allegra is currently available in 50 countries worldwide
and is backed by more than 1.5 billion patient days of
experience. Allegra was first approved for use in the
United States in July of 1996 and is considered the 7th
most successful new product launched in the past five
years (source: IMS, 1999).
Clinical Data
In
clinical trials of Allegra, the onset of action of the
drug was observed within one hour after dosing.
Additional studies have shown that allergy sufferers
continued feeling relief throughout the dosing period.
Also, Allegra was shown to relieve symptoms among
allergy sufferers in a study in which those sufferers
were exposed for five hours to extremely high
pollen
challenges in a pollen chamber. This exposure is
typically much greater than what most patients would
experience in "very high" pollen season.
Other clinical trials have demonstrated that Allegra
provides effective symptom relief without sedating side
effects or impairment of performance. Consequently,
unlike other
antihistamines in Japan, such as
Zyrtec