Advair salmeterol/fluticasone propionate regulatory update

Members of FDA's Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees overwhelmingly voted that randomized controlled trials would best evaluate serious asthma outcomes with marketed long-acting beta-2 agonists (LABAs) when added to corticosteroids compared to corticosteroids alone to treat asthma. No official vote was taken but most of the panel members agreed in an informal poll that trials with 12-month treatment periods, a total duration of 5 years, and a composite endpoint including death, intubation and hospitalizations would be adequate for adults. For children, the agreed upon endpoint was hospitalizations.

Last month, FDA said it would require manufacturers to update the labels for LABAs to treat asthma, as well as conduct additional safety studies for the drugs and develop a REMS. The agency noted that clinical trials for LABAs showed an increased risk of severe worsening of asthma symptoms, leading to hospitalization and death in some patients (see BioCentury, Feb. 22). ...