EU Panel Approves New Treatment to Ease Breathing With COPD

Marcia Frellick


October 19, 2018

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Bevespi Aerosphere (glycopyrronium/formoterol fumarate dehydrate, AstraZeneca AB) for the treatment of chronic obstructive pulmonary disease (COPD).

The drug is indicated as a maintenance bronchodilator treatment to relieve symptoms in adults with COPD. The marketing approval decision was made during the committee's October meeting.

Bevespi Aerosphere is a fixed-dose combination of a long-acting beta-2 receptor agonist (formoterol fumarate dihydrate) and a long-acting muscarinic antagonist (glycopyrronium) and will be used as a suspension for inhalation (7.2 µg/5.0 µg). The dosing is two puffs in the morning and two puffs in the evening.

One of the two components helps relax the muscles around the airways, and the other helps prevent those muscles from tightening.

Company literature notes that two 24-week trials in patients with COPD showed the combination of drugs resulted in better breathing than either of its individual medicines alone.

The company notes that Bevespi Aerosphere is not a rescue inhaler and is not used for the treatment of COPD symptoms or asthma.

The CHMP summary of opinion says the drug relieves shortness of breath, wheezing, and cough.

Small percentages of patients experienced adverse reactions, most commonly headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).

Detailed recommendations for the use of the drug will be included in the summary of product characteristics, which will be published in the European public assessment report after the marketing authorization has been granted by the European Commission, according to the summary of opinion.

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