An FDA advisory committee Tuesday unanimously recommended approval for a new combination drug product for asthma. With an eye on the product's use for moderate and severe asthma sufferers, the agency's pulmonary and allergy drugs advisory committee endorsed the safety and effectiveness of the inhaler. Salmeterol prevents airway narrowing by causing muscles to relax.
Fluticasone attacks asthma symptoms by reducing inflammation in the airways.
Over 16 million Americans suffer from asthma, which causes 450,000 hospitalizations and 5,000 deaths each year. Both drugs in the inhaler are already available separately. Serevent is also now available for children 4 and older. Glaxo relied on three pivotal clinical trials that included over 1,200 patients aged 12 and older. In two U.S. studies, patients took the combination drug over three months.