Duaklir Genuair (aclidinium/formoterol)
Duaklir Genuair (aclidinium/formoterol) 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 chronic obstructive pulmonary disease.
When compared with placebo, the combination shows a clinically relevant improvement of lung function and dyspnoea, whereas the effect on quality of life is not clearly demonstrated. It is not possible to assess whether the drug is a relevant intensification option when LABA or LAMA alone in the highest possible doses are considered clinically inadequate. The combination has only been compared with the individual components, and results have not shown any additive benefit on lung function, dyspnoea or quality of life compared with formoterol. The combination does not significantly reduce the frequency of moderate and severe exacerbations compared with placebo.
The safety profile shows typical anticholinergic and beta-adrenergic effects. The most frequent adverse events include nasopharyngitis and headache. COPD exacerbations were observed more frequently than in the placebo group, and exacerbations generally led to a dropout of treatment in <2.5% of the patients, regardless of treatment group.
When combination therapy is indicated in adult patients with COPD, it is IRF’s overall assessment that Duaklir Genuair does not demonstrate any significant therapeutic improvements 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.
Duaklir Genuair was marketed on 2 March 2015 and general reimbursement is currently granted.