RESEARCH TRIANGLE PARK, N.C. British drug maker GlaxoSmithKline issued a response to new labeling requirements proposed by the Food and Drug Administration for a class of asthma drugs that an analysis by the agency indicated may lead to an increased risk of hospitalization or death among patients.
The FDA announced Thursday that an analysis of clinical trial data for drugs known as long-acting beta-agonists, including GSK’s Advair (salmeterol and fluticasone propionate), had indicated an increased risk of worsening of symptoms and death in patients and would require them to be used in conjunction with asthma controller medications such as inhaled corticosteroids.
“We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease,” GSK VP respiratory clinical research Katharine Knobil said in a statement. “It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma.”
GSK, however, said there was no evidence from more than 10 years of clinical trials, observational studies and clinical experience that Advair was associated with increased risk of death from asthma, hospitalization or other serious problems. The drugs, also known as LABAs, are also used to treat chronic obstructive pulmonary disease, but the FDA’s requirements cover only the drugs’ use to treat asthma.
Merck and Novartis, which make the LABA Foradil Aerolizer ( formoterol fumarate), said they would work with the FDA to assess the new requirements and “determine appropriate next steps.”