FDA Rejects Sunovion's COPD Therapy

May 30, 2017

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