GSK exhibits Anoro Ellipta's superior efficacy in dual therapy in ATS conference

Anoro Ellipta's superior efficacy in dual therapy

28 May, 2022 | DelveInsight

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway restriction due to airway and/or alveolar abnormalities, usually harmful particles. DelveInsight’s estimates suggest a higher number of diagnosed prevalent population of COPD found in the seven major markets (the US, EU-5 (Germany, France, Italy, Spain, and the UK), and Japan) with approximately 32,259,000 cases in the year 2021.

Broadly, pharmacological intervention for the indication involves reliever therapies such as Short-acting Beta Agonist (SABA), Short-acting Muscarinic Antagonist (SAMA) and Oral corticosteroids and maintenance therapies such as Long-acting Muscarinic Antagonist (LAMA), Long-acting Beta Agonist (LABA) and Inhaled Corticosteroids (ICS). Additionally, maintenance treatment involves Dual therapy, including combinations of ICS/LABA and LABA/LAMA. The LAMA/ LABA brands include Duaklir Pressair (aclidinium bromide/formoterol fumarate; from Circassia Pharmaceuticals), Bevespi Aerosphere (glycopyrrolate /formoterol fumarate; from Astrazeneca), Ultibro Breezhaler (indacaterol maleate and glycopyrronium bromide; from Novartis), Stiolto Respimat (tiotropium/olodaterol; from Boehringer Ingelheim), and Anoro Ellipta (umeclidinium/vilanterol; from GSK).

Some comparative studies previously conducted to establish the safety and efficacy of the therapies were as follows:

Study (year)

Intervention Therapy

Comparator therapy

Study Results

AERISTO Study (2019)



No clinically meaningful differences between treatments in symptom endpoints. Both treatments were well tolerated with similar safety profiles.

Study A2349 (2017)

Glycopyrronium/ Indacaterol


GLY/IND and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant.

Study GSK204990 (2017)



Superiority was observed for the primary end point with UMEC/VI compared with TIO/OLO in patients with symptomatic COPD. Both treatments had similar safety profiles.


Recently, with a view to evidence better efficacy of Anoro Ellipta as COPD dual therapy, GSK presented at the American Thoracic Society (ATS) International Conference, 2022, a comparison of the efficacy of Umeclidinium/Vilanterol (UMEC/VI) and other bronchodilators in the treatment of COPD. This study included a comparative analysis of dual therapy in patients with COPD and spans 12 and 24 weeks. The results showed that UMEC/VI was statistically significant and was more effective in increasing trough FEV1 (based on mean CFB difference) at 12 weeks. At 24 weeks, UMEC/VI was statistically significant and more effective in increasing FEV1 than all comparators. The preferred long-term efficacy with UMEC/VI showed a significant improvement in trough FEV1 compared to the 24th week.

In connection with this study, other findings were also concluded, including valuable multicenter trial results on exacerbations and treatment responses in COPD patients treated with a three fixed-dose LABA / LAMA regimen (tiotropium/olodaterol (0.19), umeclidinium/vilanterol (0.17) and indacaterol/glycopyrronium (0.38)) in Taiwan. The study inferred that the annualized rates of moderate-to-severe exacerbation in patients receiving tiotropium/olodaterol or umeclidinium/vilanterol were significantly lower than those receiving indacaterol/glycopyrronium, though the time to first moderate-to-severe exacerbation was similar among different fixed-dose LABA/LAMA combinations.

As more LAMA/ LABA fixed dose inhalers have flooded the market, there has been greater interest in using them for maintenance treatment over the years. Prospectively, the study presented by GSK, showing better efficacy, is likely to offer better outlook to the drug, which is expected to go off-patent in 2027 in the US and 2029 in Europe. According to DelveInsight’s assessment of COPD market, GSK’s Anoro Ellipta will peak in the year 2026 with approximate sales of USD 850 million in the 7MM.

For more detailed analysis, visit: Chronic Obstructive Pulmonary Disease Market

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