The US FDA has approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily) for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, according to manufacturer Sunovion Pharmaceuticals Inc. The drug, which had been under development as Sun-101/eFlow, is expected to be available in US pharmacies in early 2018.
Lonhala Magnair is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the US and the first use of the Magnair delivery device, which is based on the closed eFlow technology system, developed by Pari Pharma GmbH.
This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device, according to Sunovion.
“We are proud that the FDA has approved Lonhala Magnair as the first nebulized, long-acting muscarinic antagonist treatment option for people in the US living with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “The approval of Lonhala Magnair underscores our leadership in nebulization and the value we place on providing innovative treatment options for people living with COPD. Lonhala Magnair is an important addition to our portfolio of approved COPD therapies for people at various stages of COPD, providing the flexibility to choose handheld or nebulized products based on individual needs.”
“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,” said Gary Ferguson, MD, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique handheld nebulizer that allows a person to breathe normally while taking their medication.”
The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing Lonhala Magnair with placebo in adults with moderate-to-very-severe COPD. At study endpoints, individuals treated with Lonhala Magnair demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 versus placebo.
More information is available at Sunovion’s website.