The FDA has issued a complete response letter (CRL) regarding the new drug application for SUN-101/eFlow (glycopyrrolate, Sunovion Pharmaceuticals) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion has not revealed what prompted the CRL, saying only that it does not require the company to conduct additional clinical studies.
If approved, SUN-101 would have been the first nebulized, long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD in the U.S., but the delay hands an opportunity to Theravance Biopharma and its partner Mylan to catch up with their rival COPD candidate revefenacin, according to Fierce Biotech.
SUN-101/eFlow is in development as a nebulized treatment for patients with moderate-to-very-severe COPD. The investigational combined product, consisting of SUN-101 and the investigational eFlow closed-system nebulizer, has not been approved by the FDA for the treatment of patients with COPD.
COPD is characterized by persistent respiratory symptoms and airflow limitation that are due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute to the disease. Approximately 15.7 million adults in the United States report that they have been diagnosed with COPD. It is estimated that several million more adults have undiagnosed disease.
COPD is responsible for more than 120,000 deaths per year in the U.S., making it the country’s third leading cause of death. COPD develops slowly, and the symptoms often worsen over time, potentially limiting the ability to perform routine activities. Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply, and the feeling of being unable to breathe.