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Relenza Inhaler Approved for Prevention of A and B
Flu; Stockpiled for Pandemic
Second drug option
for Americans to prevent and treat flu
 March 31, 2006 – Although not a substitute for the
flu vaccine, Relenza, an inhaler administered drug, has been approved
for prevention of influenza A and B virus infections in adults and
children. In one of the clinical trials used for the approval, which
consisted primarily of senior citizens, the percent that developed
symptoms confirmed to be flu were reduced from 1.4% of those on placebo
to 0.2% for those who used Relenza. It is being stockpiled by the U.S.
for use in a possible bird flu pandemic.
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An antiviral medication known generically as
zanamivir, Relenza, was approved Wednesday by the Food and Drug
Administration for persons age five and older. It was previously
approved for the "treatment" of influenza A and B virus infections in
adults and children.
Tamiflu (oseltamivir phosphate), which is delivered
by capsule, previously was approved for both prevention and treatment of
flu. The approval of Relenza for prevention provides Americans with a
second option for the prevention of influenza A and B infections.
"This approval is a welcome addition to the
available defenses against the flu," said Dr. Steven Galson, director of
the FDA's Center for Drug Evaluation and Research. "This new use offers
the medical community another option to prevent and control influenza A
and B."
The effectiveness of Relenza in preventing seasonal
influenza has been demonstrated in four large-scale studies comparing
the drug with placebo. In two of these trials, the use of the drug
substantially reduced the spread of influenza in the participating
households where participants were five years of age or greater. In both
of these trials, the proportion of households that developed symptoms
confirmed to be flu was 19.0% for the placebo group and 4.1% for the
Relenza group.
In the other two trials, which were conducted in
communities experiencing an influenza outbreak, Relenza reduced the
incidence of the disease in both young and older populations. In the
first study, with participants 18 years of age or older, the proportion
of people who developed symptoms confirmed to be flu was 6.1% for the
placebo group and 2.0% for the Relenza group.
The second community study enrolled people 12 to 94
years of age (56% of whom were older than 65 years). In this trial, the
percent of people who developed symptoms confirmed to be flu were
reduced from 1.4% of the participants on placebo to 0.2% for those who
used Relenza.
In all of these studies, the most common events
during treatment with Relenza in adults and adolescents were headaches;
diarrhea; nausea; vomiting; nasal irritation; bronchitis; cough; sinus
infections; ear, nose, and throat infections; and dizziness. In
children, the most common side effects were ear, nose, and throat
infections; vomiting; and diarrhea. Less common reported events included
rashes and allergic reactions, some of which were severe.
Breathing problems (bronchospasm), including
deaths, were reported in some patients after the initial approval of
Relenza. Most of these patients had asthma or chronic obstructive
pulmonary disease. Relenza therefore is not recommended for treatment or
prophylaxis of seasonal influenza in individuals with underlying airways
disease such as asthma or chronic obstructive pulmonary disease.
Relenza has not been proven effective for treatment
of influenza in people with underlying airways disease, or for
prevention of influenza in nursing homes.
The drug is also not a substitute for the flu
vaccine, which is the primary means for preventing influenza. Consumers
should continue receiving an annual flu vaccination according to
guidelines on immunization practices.
In preparation for a potential pandemic, FDA has
assembled an agency-wide Pandemic Influenza Preparedness Task Force to
provide policy leadership and strategic planning on pandemic influenza.
The Task Force is charged with developing a comprehensive plan to
accelerate the development, production, and regulatory review of
antivirals and other pandemic countermeasures.
FDA also is working with the pharmaceutical
industry to make available appropriate products and ensure that
mechanisms are in place to collect the necessary efficacy and safety
information. Both Relenza and Tamiflu have been identified for
stockpiling.
Relenza is manufactured and distributed by
GlaxoSmithKline Inc., based in Research Triangle Park, N.C.
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