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US FDA says black box warnings can be removed from GSK's Ellipta


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US FDA says black box warnings can be removed from GSK's Ellipta

GlaxoSmithKline plc said the U.S. Food and Drug Administration approved labeling changes to remove the black box warning from inhaler combination medicines used to treat asthma.

The U.S. regulator approved the removal of boxed warnings from inhaled corticosteroids, plus long-acting beta2 agonist drugs, which are used to relax muscles of the windpipe.

The U.S. FDA also approved updates to the warnings and precautions section of labeling for this particular class of medicines.

The labeling updates were based on a review of safety data from four randomized safety trials submitted by GSK and two other companies.

Breo Ellipta, or fluticasone furoate and vilanterol - FF/VI; Advair Diskus, or fluticasone propionate and salmeterol - FSC; and Advair HFA are all included in the update.

In 2010, the U.S. regulator issued a post-marketing requirement to manufacturers to conduct a large-scale study on the safety of long-acting beta2 agonists when used in combination with inhaled corticosteroids in adults and adolescents with asthma.

GSK reported results from two safety studies that compared its combination medicine Advair Diskus to fluticasone propionate alone.

The trials showed that there was no excess risk associated with Advair Diskus when used to treat both adolescent and adult patients with asthma.