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FDA approves first nebulized LAMA treatment for COPD

The US Food and Drug Administration (FDA) has approved Sunovion’s Lonhala Magnair (glycopyrrolate), making it the first nebulized long-acting muscarinic antagonist (LAMA) treatment in the United States for patients with chronic obstructive pulmonary disease (COPD). It is expected to appear in pharmacies across the United States in early 2018. 

An estimated 30 million people in the United States are affected by the condition, yet only half of these are aware they have COPD, according to figures from the Centers for Disease Control and Prevention (CDC). COPD is an umbrella term used to describe a number of progressive lung conditions, such as emphysema, asthma, bronchiectasis, and chronic bronchitis. 

The latest treatment developed by Sunovion is a twice-daily treatment for the long-term treatment of airflow obstruction in patients with COPD. The device allows patients to breathe normally while taking their medication. Gary Ferguson, MD, of the Pulmonary Research Institute of South Michigan, asserted that the new Lonhala Magnair combines effective treatment with a proven medication with a “unique” handheld nebulizer. 

“Despite the availability of several therapies, many people still struggle to control their COPD - a challenge that may be affected by the delivery method used to administer a medication,” he stated.

The Lonhala Magnair gained approval following two Phase III clinical trials, which found the product was “well-tolerated” in clinical studies and that patients experienced an improvement when their trough forced expiratory volume in one second levels were measured. The most common side effects of the Lonhala Magnair were exacerbations and cough.

In November 2017, the FDA approved a the first once-daily single inhaler triple therapy for treatment of patients with COPD. The Trelegy Ellipta (furoate, umeclidinium, vilanterol), manufactured by GlaxoSmithKline and Innoviva, features an inhaled corticosteroid, LAMA and a long-acting beta2-adrenergic agonist. Other inhalers used to treat COPD include the Advair Diskus and Anoro Ellipta.