The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed a fixed-dose combination of aclidinium bromide/formoterol fumarate (340/12 ?g) from Almirall as an inhaled maintenance bronchodilator for adults with chronic obstructive pulmonary disease (COPD).
On the basis of the quality, safety, and efficacy data submitted, the CHMP considers there to be a favorable “benefit-to-risk balance” for aclidinium bromide/formoterol fumarate, and therefore recommended granting marketing authorization, the committee said.
Aclidinium bromide is a long-acting muscarinic antagonist that acts primarily on the M3 receptor to relieve bronchospasm. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates B2-receptors, resulting in bronchodilation.
Both aclidinium bromide and formoterol fumarate are separately approved for the maintenance treatment of COPD in the United States and Europe.
The CHMP also recommended approval of a combination budesonide/formoterol (160/4.5 and 320/9 ?g) inhalation powder for the treatment of adults aged 18 years and older with asthma or COPD.
For asthma, the indications for budesonide/formoterol are for regular treatment of asthma where use of an inhaled corticosteroid and LABA is appropriate, in patients not adequately controlled with inhaled corticosteroids and as-needed inhaled short-acting LABA, or in patients already adequately controlled with both inhaled corticosteroids and LABA.
For COPD, the indication is for symptomatic treatment of severe COPD (forced expiratory volume in 1 second < 50% predicted normal) and a history of repeated exacerbations in patients who have significant symptoms despite regular therapy with long-acting bronchodilators.
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