FDA Approves New Option for COPD

The FDA has approved Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow, for the long-term maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including chonic bronchitis or emphysema.

Lonhala Magnair is the first nebulizing long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the United States. Its approval was based on data from clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, including GOLDEN-3 and GOLDEN-4, 2 Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing the treatment with placebo in adults with moderate-to-very-severe COPD.
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Individuals treated with Lonhala Magnair showed significant changes from baseline in trough forced expiratory volume in 1 second at week 12 vs placebo.

Potential serious side effects include sudden shortness of breath, allergic reactions, and new or worsening eye problems, and urinary retention problems. Common side effects include shortness of breath and urinary tract infection.

—Michael Potts

Reference:

Sunovion Receives FDA approval for Lonhala™ Magnair™ inhalation solution to treat COPD [press release]. December 5, 2017. Marlborough, Massachusetts. http://news.sunovion.com/press-release/sunovion-receives-fda-approval-lonhala-magnair-inhalation-solution-treat-copd.