FDA issues CRL for Sunovion’s COPD therapy

The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA issued a complete response letter for SUN-101 as a long-term maintenance treatment for airflow obstruction in patients with chronic obstructive pulmonary disease. SUN-101 is a formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered via the eFlow nebulizer system.

Sunovion did not disclose a specific reason for the CRL and did not respond to inquiries. The company said it will work with FDA to determine a path forward for the therapy and added it would not need to conduct additional studies...