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GlaxoSmithKline statement on FDA Advisory Committee vote on use of asthma medicines containing long-acting beta-agonists


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Washington, DC . - The following is GlaxoSmithKline’s [NYSE: GSK] statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK’s Serevent® (salmeterol) and Seretide/Advair® (fluticasone propionate and salmeterol).

“We welcome the committee’s endorsement of Seretide/Advair as a valuable treatment for asthma in adults and children,” said Dr. Ellen Strahlman, Chief Medical Officer for GSK. “We believe this recommendation is consistent with national treatment guidelines – based on evidence and developed by experts – that support the combination of a LABA and ICS as an important treatment for children and adults with persistent asthma. We will continue to work with physicians to encourage broader understanding of national guidelines for appropriate use.”

“Serevent, when used with an ICS, is an important treatment option for some patients as outlined in national guidelines. We are confident that our proposed new labeling, medication guide and risk management plan would help physicians effectively manage the appropriate use of Serevent in conjunction with an ICS,” Dr. Strahlman said. “We are concerned that - if the FDA adopts the panel’s recommendation on Serevent - it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma.”

GSK is committed to continuing discussions with the Agency as it determines next steps following the Advisory Committee meeting.

GSK conducted an analysis of more than 200 clinical studies that included more than 100,000 patients, presenting the following information to the committees:

* The clinical and observational data presented by GSK demonstrated better overall asthma control with Seretide/Advair than with a single medicine. Improvements with Seretide/Advair included better lung function and symptom control and a reduction in albuterol use.
* For Seretide/Advair, there was no evidence of increased risk for asthma-related death, hospitalization, and intubation as well as all cause death in any age group compared to other treatments studied.
* The analysis showed no increased risk of serious asthma-related events when salmeterol is used appropriately with an ICS. In fact, the combination of salmeterol with an ICS (either as Seretide/Advair or as Serevent plus an ICS) provides effective asthma control to patients by improving lung function, preventing daytime and nighttime symptoms and decreasing the use of rescue medications – all important measures of asthma control.
* There were no asthma-related deaths in children receiving Serevent or Seretide/Advair in clinical studies enrolling more than 7,400 children.
* There was an increased risk for serious asthma-related outcomes, including hospitalization, when salmeterol was used without an inhaled corticosteroid or when the use of inhaled corticosteroids could not be assured (e.g. not part of study treatment).
* Asthma is a significant public health issue in the U.S. The disease affects more than 22 million people, including more than 6 million children. Uncontrolled asthma can put patients at risk for increased asthma symptoms, sudden attacks, hospitalization and death.

Important European Information about Seretide

Seretide is an inhaled combination treatment for asthma, containing salmeterol and fluticasone propionate. Fluticasone propionate is an anti-inflammatory agent that controls airway inflammation, which is the underlying cause of asthma. Salmeterol is a long acting bronchodilator which reduces asthma symptoms (chest tightness, wheezing, cough). Seretide combines these two well established asthma treatments in one inhaler.

Seretide is approved in Europe, under the mutual recognition procedures, for use in the regular treatment of asthma where use of a combination product(long-acting beta-2-agonistand inhaled corticosteroid) isappropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta-2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.

Seretide 50 microgram /100 microgram strength is not appropriate in adults and children with severe asthma.

Important US Information about Advair Diskus

Advair Diskus is indicated for the maintenance treatment of asthma. Advair Diskus won’t replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Advair Diskus contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair Diskus is not for people whose asthma is well controlled on another controller medicine. People should speak to their doctor about the risks and benefits of treating their asthma with Advair Diskus. People taking Advair Diskus should see their doctor if their asthma does not improve. People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. Advair Diskus is for patients 4 years and older. For patients 4 to 11 years old, Advair Diskus 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.

Important US information about Serevent Diskus

Serevent Diskus is indicated for the maintenance treatment of asthma in patients 4 years of age and older. Serevent Diskus does not replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. In patients with asthma, medicines like Serevent may increase the chance of asthma-related death. People should talk to their doctor about this risk and the benefits of treating their asthma with Serevent Diskus. Serevent Diskus should not be the only controller medicine prescribed for a person’s asthma and is not a substitute for anti-inflammatory medications (inhaled or oral corticosteroids). People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. People should see their doctor if their asthma does not improve.



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