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GlaxoSmithKline ready to supply Biota's Relenza to meet CDC recommendations

Published on December 21, 2008 at 10:08 PM · No Comments

GlaxoSmithKline (GSK) is prepared to respond to public health needs for Relenza (zanamivir) Inhalation Powder this flu season following a Health Alert Advisory issued by the Centers for Disease Control and Prevention (CDC).

Relenza is a preferred medication in the CDC-issued interim recommendations for all circulating subtypes of influenza virus.

This interim guidance is based on early and limited data from the current influenza season that has detected a significant increase in the proportion of influenza A (H1N1) viruses that are resistant to Tamiflu (oseltamivir). It is not possible to predict how common the influenza A (H1N1) viruses will be during the remainder of the 2008-2009 flu season. All tested influenza virus subtypes have shown no resistance to Relenza. Clinical significance cannot be inferred from this surveillance data.

GSK has sufficient supply available of Relenza to meet 2008-2009 influenza season needs. Pharmacies can obtain Relenza from their wholesalers.

Antiviral resistance is a potentially significant issue when considering widespread use during the peak months of influenza season. GSK is committed to making Relenza available. However, this emergence also underscores the importance of receiving an annual influenza vaccination, as recommended by the CDC's Advisory Committee on Immunization Practices.

CDC's interim recommendations on the use of influenza antiviral medications in the United States for the 2008-2009 flu season was issued in a Health Alert Advisory on December 19th, 2008. Revised guidance is available at www.cdc.gov/flu .

Relenza is a medicine for the treatment of influenza and for reducing the chance of getting the flu in community and household settings. It belongs to a group of medicines called neuraminidase inhibitors. These medications attack the influenza virus and prevent it from spreading inside your body. Relenza treats the cause of influenza at its source, rather than simply masking the symptoms. Relenza is delivered via inhalation using a diskhaler. Step-by-step instructions for proper use of the diskhaler are available at www.Relenza.com, including a short instruction video.

Relenza is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease).

Serious cases of bronchospasm, including fatalities, have been reported during treatment with Relenza in patients with and without underlying airways disease. Many of these cases were reported during postmarketing and causality was difficult to assess.

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