FDA accepts NDA resubmission for SUN-101/eFlow

The US Food and Drug Administration has accepted for review the resubmission of the New Drug Application from Sunovion Pharmaceuticals for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

This resubmission is in response to the Complete Response Letter Sunovion received from the FDA on May 26, 2017, said Sunovion, a subsidiary of Japanese pharma company Sumitomo Dainippon (TYO: 4506). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is December 15, 2017.

“We look forward to working with the FDA during their review of the SUN-101/eFlowresubmission, which, if approved, would be the first nebulized LAMA for patients with COPD in the United States,” said Antony Loebel, executive vice president and chief medical officer at Sunovion, head of global clinical development for Sumitomo Dainippon Pharma Group. “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,” he added.