GSK analysis shows Seretide/Advair is a well tolerated and effective medicine for controlling asthma

London UK - The U.S. Food and Drug Administration today posted a comprehensive review conducted by GlaxoSmithKline of its clinical and observational data that demonstrated better overall asthma control with the combination medicine Seretide/Advair (fluticasone propionate and salmeterol) than with a single medicine alone. The data also presents the well-established safety record for Seretide/Advair.

The data confirmed that Serevent (salmeterol) is effective and showed no increased risk of serious asthma-related outcomes when it was used appropriately with an inhaled corticosteroid (ICS). The risk increased when Serevent was used without an ICS, or use of an ICS could not be assured. However, current treatment guidelines recommend that both ICS and a LABA be used to treat patients with moderate to severe persistent asthma. Prescribing patterns reflect adherence to these guidelines; one survey shows salmeterol is prescribed with an ICS more than 98% of the time.

Current U.S. prescribing information advises patients to take Serevent in combination with another asthma controller medicine. To strengthen adherence to the guidelines, GSK has asked the FDA to revise the product label to direct that Serevent be used only with an inhaled corticosteroid for treating asthma. This advice is already listed in the EU label for Serevent.

The safety and efficacy data in children ages 4-11 were similar to those seen in adults and adolescents.

“These findings are consistent with current standard of care and medical guidelines for controlling asthma,” said Katharine Knobil, GSK vice president for global clinical development of respiratory medicine. “Uncontrolled asthma is a significant health risk. Physicians have made great strides battling asthma through an increased understanding of the disease and optimal use of medicines to treat it. We believe the best way to continue this progress is by ensuring that doctors have access to a range of medicines to manage asthma.”

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-agonist and inhaled corticosteroid) is appropriate: 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.

GlaxoSmithKline – 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.

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.