The FDA has approved Sunovion Pharmaceutical‘s Lonhala Magnair system for the long-term treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today.
The drug-device combo, also known as Sun-101/eFlow, is the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer that delivers the drug in two to three minutes and allows the user to breathe normally while the drug is administered.
Sunovion said it expects the product to be available in pharmacies by early 2018.
“We are proud that the FDA has approved Lonhala Magnair as the first nebulized, long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD,” David Frawley, Sunovion’s EVP and chief commercial officer, said in prepared remarks. “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,” Dr. Gary Ferguson of the Pulmonary Research Institute added. “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.”
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.
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. The Marlborough, Mass.-based company did not provide any details about the complete response letter. Sunovion resubmitted the product’s NDA in June.
