FDA Approves First Nebulized Long-Acting Muscarinic Antagonist for COPD
FDA approval was supported by data from the GOLDEN 3, 4, and 5 clinical trials.
Sunovion announced that the Food and Drug Administration (FDA) has approved Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Lonhala Magnair, also known as SUN-101/eFlow, is the first nebulized long-acting muscarinic antagonist (LAMA) approved for COPD. It exerts pharmacological effects in the airways through M3 receptor inhibition at the smooth muscle leading to bronchodilation. The eFlow technology allows for a virtually silent, portable, closed system nebulizer that delivers the drug in 2 to 3 minutes while patients can breathe normally.
The FDA approval was supported by data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program, which included two Phase 3, 12-week randomized double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials (GOLDEN-3 and GOLDEN-4; NCT02347761 and NCT02347774, respectively) comparing Lonhala Magnair vs placebo in patients with moderate to very severe COPD.
Adults treated with Lonhala Magnair showed statistically significant and clinically important changes from baseline in trough forced expiratory volume in 1 second (FEV1) at week 12 vs placebo.
In a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial (GOLDEN-5; NCT02276222), Lonhala Magnair was compared to Spiriva® HandiHaler® (tiotropium bromide) in adults with moderate to very severe COPD. For all studies, Lonhala Magnair was well-tolerated and the overall treatment-emergent adverse events (TEAE) occurrences were similar for Lonhala Magnair and Spiriva groups over 48 weeks.
Lonhala Magnair is anticipated to launch in early 2018 as 1 mL single-dose vials containing 25 mcg of glycopyrrolate. It will be available as a Starter Kit or a Refill Kit providing a 30-day supply.
Sunovion receives FDA approval for Lonhala™ Magnair™ inhalation solution to treat COPD [news release]. Marlborough, MA: Sunovion Pharmaceuticals Inc. http://news.sunovion.com/press-release/sunovion-receives-fda-approval-lonhala-magnair-inhalation-solution-treat-copd. Published December 5, 2017. Accessed December 8, 2017.