GSK receives FDA approval for expanded indication for FLUARIX® QUADRIVALENT (Influenza Vaccine) for persons 6 months and older

PHILADELPHIA, Jan. 12, 2018 /PRNewswire/ -- 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.¹ There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness.² Most flu activity in the US occurs from October through May, and it usually peaks between December and February.³

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.⁴ 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.⁵ Currently, the CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.⁶

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

About FLUARIX^® QUADRIVALENT
FLUARIX^® QUADRIVALENT was first approved in 2012 in the US for the prevention of influenza disease in people 3 years of age and older. It is also approved in more than 30 other countries worldwide.

FLUARIX^® QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUARIX^® QUADRIVALENT is approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX^® QUADRIVALENT
Do not administer FLUARIX^® QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX^® QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX^® QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

If FLUARIX^® QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.

In clinical trials with FLUARIX^® QUADRIVALENT, the most common solicited local adverse reaction in adults was pain. The most common systemic adverse reactions in adults were muscle aches, headache, and fatigue. In children aged 6 through 35 months, the most common solicited local adverse reactions were pain and redness; the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, solicited local adverse reactions were pain, redness, and swelling. In children 3 through five years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLUARIX^® QUADRIVALENT for other potential adverse reactions and events).

Vaccination with FLUARIX^® QUADRIVALENT may not result in protection in all vaccine recipients.

For the full US Prescribing Information for FLUARIX^® QUADRIVALENT, visit us.gsk.com.

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.

¹ Centers for Disease Control and Prevention. Key Facts about Influenza (Flu). Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed September 27, 2017.
² 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.
³ 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.
⁴ 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.
⁵ 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.
⁶ 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

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