GSK announces US regulatory submission seeking expanded indication for Fluarix® Quadrivalent (Influenza Vaccine) for infants 6 months and older

PHILADELPHIA, March 15, 2017 /PRNewswire/ -- GSK [LSE/NYSE: GSK] today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for FLUARIX^® QUADRIVALENT (Influenza Vaccine). This vaccine is currently approved for active immunization against influenza A subtype viruses and type B viruses, in persons three years of age and older. The submission seeks an expanded indication for children six months through 35 months of age. With this approval, providers would 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 six months and up.

The sBLA application is based on a Phase III pivotal study of the efficacy of FLUARIX^® QUADRIVALENT in children six months through 35 months of age and on two supportive studies. GSK has submitted the results of the pivotal study to the European Society for Paediatric Infectious Diseases for presentation at their annual meeting on May 23 - 27, 2017, in Madrid.

About seasonal influenza in children

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-May, and it usually peaks in January and February.³

According to the US Centers for Disease Control and Prevention (CDC), the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, many children get sick with seasonal influenza and some of those illnesses result in death. On average, 20,000 children under the age of 5 are hospitalized because of influenza complications.⁴ The CDC recommends that everyone aged 6 months and older get a seasonal flu vaccine.⁵

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 U.S. for the prevention of influenza disease in people three years of age and older. It is also approved in more than 30 other countries worldwide.

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 six 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 injection site adverse reaction in adults was pain. The most common systemic adverse reactions in adults were muscle aches, headache, and fatigue. In children 3 through 17 years of age, injection site adverse reactions were pain, redness, and swelling. In children 3 through 5 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 U.S. Prescribing Information for FLUARIX^® QUADRIVALENT, visit GSKsource.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.

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 'Risk factors' in the company's Annual Report on Form 20-F for 2014.

¹ Centers for Disease Control and Prevention. Key Facts about Influenza (Flu). Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed March 2, 2017.
² Centers for Disease Control and Prevention. Types of Influenza Viruses. Available at: https://www.cdc.gov/flu/about/viruses/types.htm. Accessed March 2, 2017.
³ Centers for Disease Control and Prevention. The Flu Season. Available at: https://www.cdc.gov/flu/about/season/flu-season.htm. Accessed March 2, 2017.
⁴ Centers for Disease Control and Prevention. Children, the Flu, and the Flu Vaccine. Available at: http://www.cdc.gov/flu/protect/children.htm. Accessed March 2, 2017.  
⁵ 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 March 2, 2017.

SOURCE GSK