FDA reviewing Sunovion's COPD therapy

The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA accepted an NDA for SUN-101, a formulation of glycopyrrolate delivered via the eFlow nebulizer system as a long-term maintenance treatment for airflow obstruction in chronic obstructive pulmonary disease. The PDUFA date for the application is May 29, 2017.

Glycopyrrolate is a long-acting muscarinic antagonist (LAMA). In April, Sunovion said SUN-101 met the primary endpoint of the Phase III GOLDEN-3 and GOLDEN-4 studies to treat COPD (see BioCentury Extra, April 27). ...