FDA setback for SUN-101/eFlow for COPD

The US Food and Drug Administration on May 26 issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The drug’s developer Sunovion Pharmaceuticals, a subsidiary of Japanese pharma company Sumitomo Dainippon (TYO: 4506), says that the CRL does not require the company to conduct any additional clinical studies for the approval of SUN-101/eFlow.

The FDA accepted the SUN-101/eFlow NDA for review in October 2016, with an expected Prescription Drug User Fee Act (PDUFA) date of May 29, 2017. If approved, SUN-101/eFlow would be the first nebulized nebulized long-acting muscarinic antagonist (LAMA) for patients with COPD. We