The U.S. FDA has issued a Complete Response Letter for Sunovion Pharmaceutical's New Drug Application for a therapy aiming to treat chronic obstructive pulmonary disease.
Sunovion, the U..S subsidiary of Japan's Sumitomo Dainippon, was hoping its SUN-101/eFlow therapy would become the first nebulized long-acting muscarinic antagonist for COPD.
In a brief presss release, the MA-based biotech said that regulators were not asking for new trials and that Sunovion would work with the FDA to determine a path forward.
Read the press release