GlaxoSmithKline: Breo leads the way as the first once-daily ICS/LABA inhaler for COPD.
By Natasha Spiller, Analyst
14 May 2013
I am an Analyst at Datamonitor Healthcare. After joining the company in 2012, I have produced analysis across a number o...
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On 10 May 2013, the FDA approved Breo Ellipta (fluticasone/vilanterol), the first once-daily inhaled corticosteroid (ICS) and long-acting beta 2 agonist (LABA) combination inhaler for the treatment of chronic obstructive pulmonary disease (COPD). Developed by GlaxoSmithKline, in collaboration with Theravance, Breo is a combination of the ICS fluticasone furoate and the LABA vilanterol.
Breo’s key advantage lies not in its efficacy but in its once-daily dosing, which offers patients a substantial improvement in their dosing regimen. This will improve patient compliance, and as such, once-daily treatments are highly sought after by physicians. Datamonitor Healthcare’s 2013 survey of key opinion leaders across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) revealed that respondents expect to be treating up to 26% of severe and very severe COPD patients with once-daily ICS/LABA inhalers once they reach the market.
Breo’s clinical development program involved four pivotal studies in COPD; two 12-month exacerbation studies and two 6-month efficacy and safety studies. While clinical data for Breo are largely positive, the critical challenge during development was to demonstrate superior efficacy compared to its individual components. Although both 12-month exacerbation studies demonstrated a reduction in the annual rate of exacerbations with fluticasone/vilanterol compared to vilanterol, only one of the studies demonstrated a statistically significant difference of the combination compared to vilanterol at all doses studied (200/25mg, 100/25mg, 50/25mg). The second study failed to demonstrate a statistical significance for the highest dose. Furthermore, while the studies were able to demonstrate a numerical increase in lung function of the combination compared to vilanterol alone, again the results were not statistically significant.
Despite ambiguity regarding the overall efficacy of the combination over the individual components, the FDA’s Pulmonary-Allergy Advisory Committee voted in favor of Breo in April 2013. The committee voted that Breo provides a clinically meaningful benefit for the long-term maintenance treatment of airflow obstruction in COPD and a clinically meaningful benefit for the reduction of exacerbations.
Due to Breo’s once-daily dosing, Datamonitor Healthcare forecasts strong uptake, especially among patients previously taking Advair (fluticasone/salmeterol), GlaxoSmithKline’s twice-daily ICS/LABA treatment. The timely launch of Breo will be important for GlaxoSmithKline, as patients can switch from Advair to Breo prior to the launch of generic versions of Advair, which are anticipated to become available from 2014.
Breo will also launch ahead of Novartis’s once-daily ICS/LABA inhaler QMF149 (mometasone/indacaterol), which will allow GlaxoSmithKline to first capture patients who are waiting to switch to a simplified ICS/LABA treatment regimen. However, the overall success of once-daily ICS/LABA combination inhalers for COPD will be overshadowed by the future success of fixed-dose LABA/long-acting anticholinergic (LAMA) combination inhalers, including GlaxoSmithKline’s Anoro (umeclidinium/vilanterol), which Datamonitor Healthcare forecasts to launch in Q1 2014. Once-daily LABA/LAMA inhalers are eagerly anticipated, even more so than once-daily ICS/LABA inhalers. Datamonitor Healthcare forecasts that LABA/LAMA inhalers will become the dominant class of inhaler by 2022.