FDA Approves Dual Bronchodilator

The US Food and Drug Administration approved a long acting dual bronchodilator.

The US Food and Drug Administration (GDA) approved AstraZeneca's glycopyrrolate and formoterol fumarate inhalation aerosol (Bevespi Aerosphere) for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

The company announced the approval April 25.

The indication is for chronic bronchitis and emphysema or both but not for asthma or relief of acute bronchospasm.

Bevespi Aerosphere is a twice-daily fixed-dosed dual bronchodilator combining a long-acting muscarinic antagonist with a long-acting beta-2 agonist.

The approval is based on the drug trial called PINNACLE which showed statistically significant improvement in patients' morning pre-dose forced expiratory volume in 1 second at 24 weeks versus placebo or using the drug's ingredients separately.

Patients with acutely deteriorating COPD should not use the drug, not should it be used more often or at higher doses than recommended.

It can also have cardiovascular effects included increase in pulse rate, blood pressure or other symptoms.

Full prescribing information is here.