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GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older

Philadelphia, PA, January 11, 2018 -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent (Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

“The flu vaccine is the one vaccine that people of almost all ages – from 6-month-old infants to older adults – should receive annually,” said Patrick Desbiens, Senior Vice President, US Vaccines. “The expanded indication for Fluarix Quadrivalent in the US builds upon GSK's commitment to being a reliable supplier and partner to healthcare providers and their patients. We can now offer two flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness."

With this approval, providers will be able to use the same dose of Fluarix Quadrivalent (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from 6 months of age and up.

The supplemental Biologics License Application was based on a Phase III pivotal study of the efficacy of Fluarix Quadrivalent in children 6 months through 35 months of age and on two supportive studies.

About Seasonal Influenza

Seasonal influenza (the “flu”) is a contagious respiratory illness, caused by flu viruses.[i] There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness.[ii] Most flu activity in the US occurs from October through May, and it usually peaks between December and February.[iii]

While anyone can get the flu, it can be particularly serious for young children, older people, pregnant women and people with certain health conditions, such as asthma.[iv] According to the US Centers for Disease Control and Prevention (CDC), the best tool available to help protect yourself and those around you against the flu is to get vaccinated. The more people who are vaccinated, the less chance the virus has to spread.[v] Currently, the CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.[vi]

For more information about flu, visit www.flu.gov and www.cdc.gov/flu.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information, please visit www.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

[i] Centers for Disease Control and Prevention. Key Facts about Influenza (Flu). Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed September 27, 2017.
[ii] Centers for Disease Control and Prevention. Types of Influenza Viruses. Available at: https://www.cdc.gov/flu/about/viruses/types.htm. Accessed September 27, 2017.
[iii] Centers for Disease Control and Prevention. The Flu Season. Available at: https://www.cdc.gov/flu/about/season/flu-season.htm. Accessed September 27, 2017.
[iv] Centers for Disease Control and Prevention. People at High Risk of Developing Flu–Related Complications. Available at: https://www.cdc.gov/flu/about/disease/high_risk.htm. Accessed December 4, 2017.
[v] Centers for Disease Control and Prevention. What Would Happen If We Stopped Vaccinations? https://www.cdc.gov/vaccines/vac-gen/whatifstop.htm. Accessed December 4, 2017.
[vi] Centers for Disease Control and Prevention. Vaccination: Who Should Do It, Who Should Not and Who Should Take Precautions. Available at: https://www.cdc.gov/flu/protect/whoshouldvax.htm. Accessed September 27, 2017.

Source: GSK

Posted: January 2018

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