GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted.
The FDA’s action relates to asthma and does not pertain to the chronic obstructive pulmonary disease (COPD) indication for Advair. The available data were reviewed by three FDA advisory committees that met jointly in December 2008 and voted that Advair has a positive benefit-risk profile as currently labelled for adult patients.
Data show that Advair has a favorable safety profile and is effective in treating asthma by improving lung function, reducing and helping to prevent symptoms, and reducing the need for rescue medicine compared to inhaled corticosteroid (ICS). There was no evidence in clinical trials for Advair of increased risk for asthma-related death, asthma-related hospitalization, asthma-related intubation or all cause death compared to other treatments options.
Observational studies showed a decrease in asthma-related hospitalization in adults receiving Advair versus ICS alone, and a decrease in asthma-related hospitalizations and emergency department visits in children receiving Advair versus ICS alone and versus ICS plus montelukast.
Katharine Knobil, vice president of respiratory clinical research at GSK, said: “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. It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma.”