Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo.
The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application.
The U.S. regulatory watchdog is slated to make a decision for the resubmitted application by December 15.
Sunovion’s investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients.
“We look forward to working with the FDA during their review of the SUN-101/eFlow resubmission, which, if approved, would be the 1st nebulized LAMA for patients with COPD in the United States,” Dr. Antony Loebel, exec VP & chief medical officer, said in prepared remarks. “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.”
Sunovion faces competition from Theravance Biopharma, Inc. (NSDQ:TBPH) and Mylan(NSDQ:MYL), which is developing its own nebulized bronchodilator to treat COPD.
