Anoro (umeclidinium/vilanterol) combines a long-acting muscarinic receptor antagonist (LAMA) with a long-acting beta-2-agonist (LABA) and is indicated for bronchodilating maintenance treatment to relieve symptoms in adult patients with COPD.
When compared with placebo, Anoro shows a clinically relevant improvement of the lung function, dyspnoea and quality of life. Generally, it is not possible to assess whether Anoro is a relevant intensification option when LABA or LAMA alone in the highest possible doses are considered clinically inadequate. Anoro has not been compared with existing LABA treatment. Results have not shown any clear improvement of the lung function when compared with tiotropium due to great variation between the average FEV1 and differences in response rates. However, the response rate for quality of life is higher for Anoro.
It is not possible to assess the effect on COPD exacerbations, which is why Anoro is generally not recommended for patients with high exacerbation risk. The safety profile shows typical anticholinergic and beta-adrenergic effects, although cough and pharyngitis were significantly more frequent than in the placebo group. COPD exacerbations with and without pneumonia were rare, while pneumonia alone was an uncommon event.
When combination therapy is indicated, it is IRF’s overall assessment that Anoro does not demonstrate any significant therapeutic improvements in COPD treatment and that less expensive alternatives are available depending on the severity of the disease and dosage requirements. IRF assesses that there are class effects within the LAMA and LABA groups, and consequently COPD patients should always be treated with the cheapest drug analogues in the cheapest inhalation system.
Anoro was marketed on 1 September 2014 and general reimbursement is currently granted.