Breo Ellipta (vilanterol/fluticasone) matches Advair in RCT

Breo Ellipta (GlaxoSmithKline) is the first FDA-approved combination product with a once-daily long acting beta agonist (vilanterol) and inhaled corticosteroid (fluticasone). Additional once daily combination ICS/LABA and LABA/antimuscarinics are expected to launch over the next decade, increasing the options for treatment of asthma and COPD.

GSK got good news in the October Chest, with the publication of a study showing Breo Ellipta (once daily fluticasone/vilanterol) measured up well in a randomized trial against Advair (twice-daily fluticasone/salmeterol) for adults and adolescents with persistent asthma.

Ashley Woodcock et al randomized 806 patients with asthma (FEV1 40-80% predicted, with bronchodilator response) to receive either q.h.s. vilanterol/fluticasone or b.i.d. salmeterol/fluticasone, while also using a placebo dummy version of the other inhaler.

After 6 months, both groups had equivalent improvements in FEV1 (+341 mL for Breo Ellipta and +377 mL for Advair), quality of life questionnaire scores, and asthma control scores. There were no differences in asthma exacerbation rates and no adverse events attributed to either inhaler.

Breo Ellipta is at this writing only FDA-approved for the treatment of COPD. (European regulators recommended its approval there as an asthma treatment, as well.) Adding an asthma indication in the U.S. would vastly increase Breo Ellipta's market potential for GSK. About 12 million U.S. adults have COPD, but 25 million are estimated to have asthma.

The once-daily products coming into the marketplace should make medication adherence easier for patients, but will also sell at premium brand prices just as established drugs like Advair (which sold almost $8 billion a year at its peak) are coming off patent. The FDA has signaled it will set a low bar for generic copies of Advair to gain regulatory approval.

Ashley Woodcock et al. Efficacy and Safety of Fluticasone Furoate/Vilanterol Compared With Fluticasone Propionate/Salmeterol Combination in Adult and Adolescent Patients With Persistent Asthma:A Randomized Trial. Chest. 2013;144(4):1222-1229. doi:10.1378/chest.13-0178