Sunovion’s NDA for Lonhala Magnair glycopyrrolate inhalation solution (formerly known as SUN-101/eFlow) has been approved by the FDA for the treatment of COPD, the company said. A US launch is planned in early 2018.
In April 2016, Sunovion announced that the Phase 3 GOLDEN-3 and GOLDEN-4 studies had met their primary endpoints. The company’s initial NDA for the product was accepted for review in October 2016; however the FDA issued a complete response letter to that application in May 2017. Sunovion resubmitted the NDA in June 2017.
Sunovion Executive VP and Chief Commercial Officer David Frawley commented, “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. 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.”
Read the Sunovion press release.