CHMP Backs Dual-Action Bronchodilators for COPD

Megan Brooks

July 26, 2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 2 new once-daily inhaled bronchodilators for maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.

The medications (Ultibro Breezhaler and Xoterna Breezhaler, Novartis Europharm) contain a fixed-dose combination of indacaterol (85 μg), a long-acting beta-2-adrenergic agonist, and glycopyrronium bromide (43 μg), a long-acting muscarinic antagonist .

Indacaterol activates the relaxation of the muscles of the airways, and glycopyrronium blocks the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways, the CHMP notes in a statement.

The committee said the combination has a favorable benefit-to-risk balance, based on the quality, safety, and efficacy data submitted, and that it "therefore recommends the granting of the marketing authorization."

A pharmacovigilance plan will be implemented for both products as part of the marketing authorization, according to the CHMP.

Detailed recommendations for the use of these products will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, the CHMP said.

Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a few months.


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