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Relenza (Zanamivir for
Inhalation) for Flu: New Drug Application Submitted
10/27/98
Press Release: Research Triangle
Park, North Carolina, October 27, 1998 –
Glaxo Wellcome announced today
that it has submitted a new drug application to the Food and
Drug Administration (FDA) for approval to market
Relenza®(zanamivir for inhalation) for treatment of influenza
A and B.
In clinical trials, Relenza was
shown to alleviate major flu symptoms faster than placebo,
when administered within two days after onset of symptoms.
Clinical trials included adults and adolescents over the age
of 12 with influenza A and B.
The submission includes data from
three Phase III clinical trials. These data show that Relenza
reduced the severity and duration of flu sufferers’ symptoms 1
to 2.5 days faster than placebo. The submission also includes
data which showed that when Relenza was taken within 36 hours,
flu symptoms among high risk patients, defined primarily as
the elderly and those with respiratory and cardiovascular
disease, were alleviated 1.5 to 2.5 days sooner than placebo.
In clinical trials, Relenza was well tolerated in the majority
of patients. The most common side effects were diarrhea,
nausea, nasal signs and symptoms, and headache. (Each side
effect occurred at a frequency of 3 percent or less,
comparable to the frequencies in patients receiving
placebo.)
Patients inhale Relenza orally
using a hand-held, breath-activated device called a
Diskhaler®. When the patient takes a breath, Relenza is
delivered directly to the surface of the respiratory tract,
the primary site of infection where the influenza virus
replicates. Over 6,000 patients worldwide have participated in
clinical trials to date.
Relenza is a potent, selective
inhibitor of neuraminidase in influenza viruses, belonging to
a new class of compounds called neuraminidase inhibitors.
Neuraminidase is an enzyme, which breaks the bond holding new
virus particles to the infected cell. Once broken, the new
viruses are free to infect other cells, spreading the
infection. Inhibiting breakage of the bond will prevent the
release of the new viruses, therefore interrupting the spread
of infection within the respiratory system.
The drug was invented in
Australia in the 1980s and licensed to Glaxo Wellcome by the
Australian company, Biota Holdings, Inc. The license gives
Glaxo Wellcome the right to develop and market Relenza
worldwide.
Biota is an Australian listed
company (BTA), based in Melbourne and engaged in funding and
management of a research and development program focusing
principally on the discovery of new human pharmaceuticals for
the treatment of viral respiratory diseases and
cancer.
Glaxo Wellcome Inc.,
headquartered in Research Triangle Park, N.C., is one of the
nation’s leading research-based pharmaceutical firms. A
subsidiary of London based Glaxo Wellcome plc, the company is
committed to fighting disease by bringing innovative medicines
and services to patients and to the healthcare providers who
serve them.
SOURCE Glaxo Wellcome
Inc
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