Sunovion Pharmaceuticals launched its Lonhala Magnair drug in the U.S. for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today.
Sunovion touts its drug as the first nebulized long-acting muscarinic antagonist approved to treat COPD in the U.S. The product is delivered using the Magnair nebulizer system, which is designed to administer medication in two to three minutes.
“Sunovion is pleased that Lonhala Magnair is now available as a treatment option for people in the U.S. living with COPD,” David Frawley, EVP & chief commercial officer, said in prepared remarks. “COPD is a serious, progressive respiratory disease affecting millions of Americans. Bringing this product to market exemplifies Sunovion’s commitment to advancing new therapeutic options for people with COPD, especially those seeking nebulized solutions to manage their COPD symptoms.”
In late-stage trials, patients treated with Lonhala Magnair had statistically significant changes from baseline in trough forced expiratory volume in one second after 12 weeks compared to people given a placebo.
And in a safety trial comparing Lonhala Magnair with Boehringer Ingelheim‘s Spiriva, Sunovion’s therapy was well-tolerated and demonstrated a similar rate of treatment-emergent adverse events over the course of 48 weeks.
Sunovion’s first application seeking approval for Lonhala Magnair was denied by the FDA in May of 2017. The Marlborough, Mass.-based company did not provide any details about the complete response letter. Sunovion resubmitted the product’s NDA in June last year and won FDA approval in December.