WASHINGTON, Dec. 11 The following isGlaxoSmithKline's (NYSE: GSK) statement regarding recommendations of acombined Advisory Committee to the FDA on the use of asthma medicinescontaining long-acting beta agonists, including GSK's Serevent(R) (salmeterol)and Advair(R) (salmeterol/fluticasone proprionate).
"We welcome the committee's endorsement of Advair as a safe and effectivetreatment for asthma in adults and children," said Dr. Ellen Strahlman, ChiefMedical Officer for GSK. "We believe this recommendation is consistent withnational treatment guidelines -- based on evidence and developed by experts --that support the combination of a LABA and ICS as a preferred treatment forchildren and adults with persistent asthma. We will continue to work withphysicians to encourage broader understanding of national guidelines forappropriate use."
"Serevent, when used with an ICS, is an important treatment option forsome patients as outlined in national guidelines. We are confident that ourproposed new labeling, medication guide and risk management plan would helpphysicians safely manage the appropriate use of Serevent in conjunction withan ICS," Dr. Strahlman said. "We are concerned that -- if the FDA adopts thepanel's recommendation on Serevent -- it is possible that Serevent would beseverely restricted and deny patients needed treatment for optimal care oftheir asthma."
GSK is committed to continuing discussions with the Agency as itdetermines next steps following the Advisory Committee meeting.
GSK conducted an analysis of more than 200 clinical studies that includedmore than 100,000 patients, presenting the following information to thecommittees:
-- The clinical and observational data presented by GSK demonstratedbetter overall asthma control with Advair than with a single medicine.Improvements with Advair included better lung function and symptom control anda reduction in albuterol use.
-- For Advair, there was no evidence of increased risk for asthma-relateddeath, hospitalization, and intubation as well as all cause death in any agegroup compared to other treatments studied.
-- The analysis showed no increased risk of serious asthma-related eventswhen salmeterol is used appropriately with an ICS. In fact, the combinationof salmeterol with an ICS (either as 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 rescuemedications -- all important measures of asthma control.
-- There were no asthma-related deaths in children receiving Serevent orAdvair 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 inhaledcorticosteroid 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 diseaseaffects 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 Information about Advair Diskus
Advair Diskus is indicated for the maintenance treatment of asthma. AdvairDiskus won't replace fast-acting inhalers for sudden symptoms and should notbe taken more than twice a day. Advair Diskus contains salmeterol. Inpatients with asthma, medicines like salmeterol may increase the chance ofasthma-related death. So Advair Diskus is not for people whose asthma is wellcontrolled on another controller medicine. People should speak to their doctorabout the risks and benefits of treating their asthma with Advair Diskus.People taking Advair Diskus should see their doctor if their asthma does notimprove. People should tell their doctor if they have a heart condition orhigh blood pressure. Some people may experience increased blood pressure,heart rate, or changes in heart rhythm. Advair Diskus is for patients 4 yearsand older. For patients 4 to 11 years old, Advair Diskus 100/50 is for thosewho have asthma symptoms while on an inhaled corticosteroid.
Important information about Serevent Diskus
Serevent Diskus is indicated for the maintenance treatment of asthmain patients 4 years of age and older. Serevent Diskus does not replacefast-acting inhalers for sudden symptoms and should not be taken more thantwice a day. In patients with asthma, medicines like Serevent may increase thechance of asthma-related death. People should talk to their doctor about thisrisk and the benefits of treating their asthma with Serevent Diskus. SereventDiskus should not be the only controller medicine prescribed for a person'sasthma and is not a substitute for anti-inflammatory medications (inhaled ororal corticosteroids). People should tell their doctor if they have a heartcondition or high blood pressure. Some people may experience increased bloodpressure, heart rate, or changes in heart rhythm. People should see theirdoctor if their asthma does not improve.
GlaxoSmithKline -- one of the world's leading research-basedpharmaceutical and healthcare companies -- is committed to improving thequality of human life by enabling people to do more, feel better and livelonger.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, GSK cautions investors that any forward-looking statementsor projections made by GSK, including those made in this announcement, aresubject to risks and uncertainties that may cause actual results to differmaterially from those projected. Factors that may affect GSK' s operations aredescribed under 'Risk Factors' in the 'Business Review' in the company' sAnnual Report on Form 20-F for 2007.