New Asthma Inhalant Backed for FDA Approval
New Asthma Inhalant Backed for FDA Approval
Nov. 23, 1999 (Bethesda, Md.) -- 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.
The product, Glaxo Wellcome's Advair Diskus (salmeterol/fluticasone), is poised to be the first in America to combine a medication that opens the airways with an inhaled steroid.
Panel chairman Curtis Sessler, MD, tells WebMD, "It is really appropriate for somebody who has moderate to severe asthma." He says, "If you have mild asthma, there are probably simpler approaches -- an inhaled steroid, a controller -- but just a single drug."
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. Flovent (fluticasone) was approved in March 1996 by the FDA for individuals 12 and older. Serevent (salmeterol) got the FDA's nod for those 12 and older in September 1994. 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.
Glaxo medical director Tushar Shah, MD, tells WebMD, "We saw significant improvements in [lung] function and asthmatic symptoms compared to each of the individual [drugs] alone." Glaxo reported from its trials that adherence to the combination was greater than 90% in all groups, notably higher than for the comparison treatments.
Advair appeared to have no serious side effects. Side effects noted with Flovent include upper respiratory infection and headache. For Serevent, the main effects are headache and congestion.
The advisory panel did voice concerns over at least one issue -- members want the drug's labeling to reflect that the firm's studies did not involve patients with mild asthma, but only those with moderate and severe symptoms. Concerned about overtreatment, the panel voted against allowing the treatment to be used for those patients who frequently use inhaled medications to treat acute asthma attacks.
New Asthma Inhalant Backed for FDA Approval
Nov. 23, 1999 (Bethesda, Md.) -- 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.
The product, Glaxo Wellcome's Advair Diskus (salmeterol/fluticasone), is poised to be the first in America to combine a medication that opens the airways with an inhaled steroid.
Panel chairman Curtis Sessler, MD, tells WebMD, "It is really appropriate for somebody who has moderate to severe asthma." He says, "If you have mild asthma, there are probably simpler approaches -- an inhaled steroid, a controller -- but just a single drug."
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. Flovent (fluticasone) was approved in March 1996 by the FDA for individuals 12 and older. Serevent (salmeterol) got the FDA's nod for those 12 and older in September 1994. 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.
Glaxo medical director Tushar Shah, MD, tells WebMD, "We saw significant improvements in [lung] function and asthmatic symptoms compared to each of the individual [drugs] alone." Glaxo reported from its trials that adherence to the combination was greater than 90% in all groups, notably higher than for the comparison treatments.
Advair appeared to have no serious side effects. Side effects noted with Flovent include upper respiratory infection and headache. For Serevent, the main effects are headache and congestion.
The advisory panel did voice concerns over at least one issue -- members want the drug's labeling to reflect that the firm's studies did not involve patients with mild asthma, but only those with moderate and severe symptoms. Concerned about overtreatment, the panel voted against allowing the treatment to be used for those patients who frequently use inhaled medications to treat acute asthma attacks.
