Posted by Michael Wonder on 07 Dec 2017
Sunovion receives FDA approval for Lonhala Magnair inhalation solution to treat COPD
5 December 2017 - Lonhala Magnair is the first nebulised long-acting muscarinic antagonist approved for the treatment of COPD in the U.S.
Sunovion Pharmaceuticals today announced that the U.S. FDA approved the new drug application for 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 people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion expects Lonhala Magnair to be available in U.S. pharmacies in early 2018.
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, randomised, 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. An additional study, GOLDEN-5, was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long-term safety and tolerability of Lonhala Magnair in adults with moderate-to-very-severe COPD and included the active comparator Spiriva (tiotropium bromide) delivered by the HandiHaler device. Lonhala Magnair was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks.
