GlaxoSmithKline has announced it has received approval by the US Food and Drug Administration (FDA) of labelling changes to remove the boxed warning from inhaled corticosteroid (ICS) / long-acting beta2 agonist (LABA) combination medicines, including BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI), ADVAIR DISKUS (fluticasone propionate/salmeterol, FSC) and ADVAIR HFA. The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class. These labelling updates were approved on December 20, 2017, after a review of safety data from 4 randomized controlled safety trials submitted by three companies, including GSK.
This decision follows a Post-Marketing Requirement, issued by the FDA in 2010, for manufacturers of LABA-containing medicines at that time indicated for the treatment of asthma, to each conduct a large-scale study on the safety of LABAs when used in combination with ICS in adults and adolescents with asthma. Each of the large-scale safety trials were randomised, double-blind, 26-week, active-controlled clinical trials comparing the sponsor-specific ICS/LABA to the same dose of the ICS. As the manufacturer of FSC, the only ICS/LABA approved in children 4-11 years of age in the US at that time, GSK also conducted a separate, similarly-designed study in this age group.
GSK reported results from two safety studies that compared FSC, an ICS/LABA combination containing Fluticasone Propionate (FP) and salmeterol, to FP alone. The studies showed that there was no excess risk associated with salmeterol when used in combination with FP, when used to treat both adolescent and adult patients with asthma (AUSTRI, SAS115359), and children aged 4 – 11 years (VESTRI, SAS115358), as assessed by the composite endpoint of asthma-related events (death, intubations or hospitalisations). Both studies were completed ahead of the predefined FDA date of June 2017.
Gsk receives us fda, label update on ics, laba combinations, asthma
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