EC's CHMP Recommends Combo Inhalers for COPD, Asthma

Megan Brooks

September 26, 2014

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 μg) 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.

If approved by the European Commission (EC), the drug will be marketed in Europe under the trade names Duaklir Genuair and Brimica Genuair.

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 reviewed efficacy and safety data for aclidinium bromide/formoterol fumarate twice daily from more than 2000 patients with COPD. The clinical program included 11 clinical studies conducted in 29 countries worldwide, Almirall says in a news release.

In phase 3 studies, compared with placebo, aclidinium bromide/formoterol fumarate twice daily "consistently provided clinically meaningful improvements" in lung function, as well as daily symptoms of COPD such as breathlessness, the company says.

A pooled efficacy analysis of data showed a statistically significant 29% reduction in the rate of moderate or severe COPD exacerbations with aclidinium bromide/formoterol compared with placebo. An improvement in health-related quality of life was also observed in clinical studies.

The most common adverse effects are nasopharyngitis and headache.

Budesonide/Formoterol Combo for Asthma, COPD

The CHMP also recommended approval of a combination budesonide/formoterol (160/4.5 and 320/9 μg) inhalation powder for the treatment of adults aged 18 years and older with asthma or COPD.

Separately, they recommended the same budesonide/formoterol combination, called Vylaer Spiromax. Both products are from Teva Pharma B.V.

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.

The EC generally follows the recommendations of the CHMP and delivers its final decision within 3 months after the CHMP recommendation.


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