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| |  FDA Approves Relenza For The Treatment Of Influenza A and B RESEARCH TRIANGLE PARK, NC -- July 27, 1999 -- The United States Food and Drug Administration has approved Glaxo Wellcome’s Relenza(R) (zanamivir for inhalation), the first and only treatment for both influenza A and B. The drug is indicated for treatment of uncomplicated acute illness due to influenza virus in adults and adolescents 12 years and older who have been symptomatic for no more than two days. Patients inhale Relenza orally using a hand-held, breath-activated device called a Diskhaler. A couple of puffs delivers Relenza to the surface of the lungs, the primary site of influenza infection, where the drug is thought to inhibit the virus from multiplying. Administered within the first two days of symptom onset, Relenza reduces the duration of flu-related symptoms. Patients orally inhale 10 mg of Relenza twice a day for five days. Relenza belongs 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. Relenza is thought to work by inhibiting breakage of the bond and preventing release of the new viruses, therefore interrupting the spread of infection within the respiratory tract. Influenza, or flu, is a viral infection that resides primarily in the lungs and typically causes significant disease that can be incapacitating. Flu affects 25 to 50 million people each year in the U.S., the majority of whom are not vaccinated. During an average year, influenza causes 20,000 to 40,000 excess deaths, results in as many as 300,000 hospitalisations and the combined direct and indirect costs of flu-related healthcare are about $12 billion per year. Symptoms of flu may begin suddenly and start with fever, body aches and cough. Usually there is severe fatigue and a loss of appetite. Untreated, flu can last up to 10 days. "Influenza is a serious infection, which deserves anti-viral intervention," said Jacob Lalezari, M.D., director of Quest Clinical Research and an assistant clinical professor of medicine at UCSF/Mount Zion Hospital. "The ability of Relenza to fight the flu should make it a valuable resource for doctors and patients in the battle against this ancient and dreaded illness. In order to treat flu effectively, patients will need to recognise the symptoms of flu and contact their healthcare provider at the first sign of symptoms." The most common side effects occurred in three percent or less of patients, were at rates comparable to placebo and included sinusitis, diarrhea and nausea. Patients should receive adequate instruction on proper use of the Diskhaler. Safety and efficacy in patients with asthma or other chronic lung or heart disease have not been established.
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