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| |  FDA Advisory Committee Recommends Approval Of Advair Diskus For Asthma RESEARCH TRIANGLE PARK, NC -- November 24, 1999 -- An advisory committee to the Food and Drug Administration today unanimously recommended for approval the first combination medication for asthma in the United States. The new medication, Advair Diskus (salmeterol xinafoate/fluticasone propionate inhalation powder), combines an inhaled corticosteroid and a long-acting inhaled bronchodilator to simultaneously treat both of the underlying causes of asthma symptoms: inflammation (swelling and irritation of the lungs' airways) and bronchoconstriction (tightening of the smooth muscle surrounding the airways).
Advair Diskus combines two leading asthma controller medications Serevent® (salmeterol xinafoate), a long-acting inhaled bronchodilator, and Flovent® (fluticasone propionate), an inhaled corticosteroid, in a single asthma medication. It is intended for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older where combination therapy is appropriate. "A new medication that combines an inhaled corticosteroid and a long-acting inhaled bronchodilator has important advantages for patients with persistent asthma," said Dr. James Donohue, professor of Medicine, Division of Pulmonary Medicine at the University of North Carolina at Chapel Hill School of Medicine. "It treats both components of the disease at the same time and thereby provides significantly better asthma control than can be achieved with either of its component agents alone." Medications to treat the inflammation and bronchoconstriction associated with asthma are often used concurrently in asthma management. National Heart, Lung, and Blood Institute management guidelines(1) indicate that inhaled corticosteroids are the most effective anti-inflammatory treatment for persistent asthma. Furthermore, a number of published studies have demonstrated that using a long-acting inhaled bronchodilator with an inhaled corticosteroid offers significantly greater levels of asthma control than using higher doses of inhaled corticosteroids. Management guidelines recommend this approach as one of the preferred treatment options for asthma patients who have daily symptoms. Three pivotal trials were conducted for Advair Diskus. Two placebo-controlled studies demonstrated the superiority of Advair Diskus 100 mcg and 250 mcg, respectively, over their individual components at the same doses. A third study, with Advair Diskus 500 mcg, demonstrated its superiority over fluticasone propionate at the same dose. Two of the pivotal trials demonstrated that Advair Diskus was significantly more effective at improving lung function (FEV(1)) than its individual components used alone. In patients who were taking an inhaled corticosteroid or salmeterol at baseline, the lowest strength of Advair Diskus (100 mcg) improved FEV(1) by 25 percent, compared with 15 percent for fluticasone propionate and 5 percent for salmeterol. Similar results were seen in the other study with Advair Diskus 250 mcg, in which all patients were taking an inhaled corticosteroid at baseline. "Clinical trials demonstrate that Advair Diskus offers asthma patients a significantly greater level of control than using either drug alone," said Dr. Tushar Shah, Director, U.S. Respiratory Clinical Development for Glaxo Wellcome Inc. "Furthermore, a combination product may simplify treatment, which is important in a disease that often requires multiple medications to bring it under adequate control." In all trials, Advair Diskus had a safety profile similar to that of its individual components. The most common side effects observed in the studies were upper respiratory tract infection, sore throat, viral respiratory infection and headache. Advair Diskus has three dose strengths: Advair Diskus 100 mcg, Advair Diskus 250 mcg and Advair Diskus 500 mcg. Each contains 50 mcg of salmeterol and either 100 mcg, 250 mcg or 500 mcg of fluticasone propionate. Patients take one inhalation in the morning and one at night, approximately 12 hours apart. The Diskus is an easy-to-use, breath-activated, powder delivery device with a dose counter to help patients keep track of remaining doses of medication. Each Diskus contains 60 pre-measured doses of drug, a 30-day supply. Because the medication is pre-measured and inhaled by the intake of the patient's own breath-rather than the force of a propellant-Diskus is able to deliver consistent dosing over a range of inspiratory (inhalation) flow rates. Recent research(2) reveals that, despite the availability of national treatment guidelines and effective medicines, asthma control in the U.S. is sub-optimal. Many patients continue to suffer from poorly controlled asthma, including frequent symptoms, exacerbations requiring urgent care, activity limitations and missed work and school. Asthma prevalence continues to rise. According to a December 1998 report issued by the Centers for Disease Control and Prevention, an estimated 17.3 million Americans live with asthma(3). Asthma accounts for an estimated 466,000 hospitalizations, 1.9 million urgent care visits, and 5000 deaths each year(4,5). It also accounts for more than $6 billion a year in healthcare costs(6), 10 million missed school days a year, and an estimated $1 billion in lost productivity by working parents caring for children who miss school due to asthma(7). References: (1) Practical Guide for the Diagnosis and Management of Asthma, National Heart, Lung, and Blood Institute, National Institutes of Health. NIH Publication No. 97-4053, October 1997.
Related Links: FloventŪ (fluticasone propionate) and Glaxo Wellcome Inc.
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