FDA Approves Flovent HFA for Children Four to Eleven

FDA Approves Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol for Children Four to Eleven

For the First Time the Most Prescribed Inhaled Corticosteroid Now Available in an Environmentally-Friendly Aerosol for Children

RESEARCH TRIANGLE PARK, N.C., March 23, 2006 -- GlaxoSmithKline announced that the U.S. Food and Drug Administration has approved the use of Flovent HFA in children four to eleven years of age with asthma. Flovent HFA, an important medicine in the treatment of asthma, is an inhaled corticosteroid (ICS) which helps prevent airway inflammation associated with asthma. Now children with asthma as young as four years of age can benefit from the most prescribed ICS in an environmentally-friendly aerosol formulation.

Flovent HFA is a reformulation of the asthma medication Flovent (fluticasone propionate) Inhalation Aerosol which uses hydrofluoroalkane (HFA-134a) to propel the medication out of the canister and into the lungs. Hydrofluoroalkane replaces the chlorofluorocarbon (CFC) propellant and is more ozone friendly. This approval supports GSK's commitment to a CFC-free portfolio of respiratory products.

Asthma in Children

According to the U.S. Centers for Disease Control nine million children under the age of 18 have been diagnosed with asthma and 3.6 million of those children are between the ages of five and 11. A recent survey of children with asthma in America showed that 42% of children with asthma had some form of urgent or emergency care visit for their asthma in the past year. More than half of children with asthma have experienced an asthma attack so bad that they had to go to an emergency room or a doctor right away. And more than a quarter of children with asthma have experienced an asthma attack so bad they had to be hospitalized. Additionally, children with asthma miss more than 12 million school days every year, making asthma the number one cause of school absences due to chronic conditions.

Flovent HFA

Flovent HFA is an ICS that helps to reduce inflammation in the airways - one of the main components of asthma. Flovent HFA was first approved by the Food and Drug Administration in May 2004 for patients 12 years of age and older and is now indicated for the maintenance treatment of asthma as a preventative therapy in patients four years of age and older. Flovent HFA is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. While adjusting to a switch from an oral steroid, like prednisone, to Flovent HFA, patients may be less able to heal after surgery, infection or serious injury. Flovent HFA does not replace fast- acting inhalers for sudden symptoms. Dosage for pediatric patients four to 11 years of age is 88 mcg twice daily.

Clinical Trials

Flovent HFA 88 mcg twice daily improved peak expiratory flow, reduced daily rescue albuterol use, and reduced nighttime awakenings due to asthma as compared to placebo over 12 weeks in children four to 11 years of age with persistent asthma. Adverse events with Flovent HFA were similar to placebo. Additional safety and efficacy of Flovent HFA for children four to 11 is supported by clinical studies in patients 12 years of age and older, pharmacokinetic studies in patients four to 11 years of age, and the established efficacy of fluticasone proprionate in other formulations for patients four to 11 years of age.

Source: GlaxoSmithKline

Posted: March 2006


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