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.
GSK
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Gary
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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.
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visit:http://www.prnewswire.com/news-releases/gsk-announces-us-regulatory-submission-seeking-expanded-indication-for-fluarix-quadrivalent-influenza-vaccine-for-infants-6-months-and-older-300424092.html
SOURCE GSK