The FDA has accepted for review Sunovion’s resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA in May 2017. The PDUFA date for the resubmitted NDA is December 15, 2017.
The original NDA was accepted for review in October 2016 and was supported by data from the GOLDEN-3, GOLDEN-4 and GOLDEN-5 trials. No additional clinical studies were required for resubmission.
Sunovion Executive VP and Chief Medical Officer Antony Loebel commented, “We look forward to working with the FDA during their review of the SUN-101/eFlow resubmission, which, if approved, would be the first nebulized LAMA for patients with COPD in the United States. Building on the strength of our heritage in nebulized treatment for COPD, the development of this innovative drug-device combination underscores our commitment to ensuring patients have choices in medication and delivery options with the goals of individualizing and optimizing treatment.”
Read the Sunovion press release.
