Sunovion to seek FDA approval for COPD treatment
Sunovion is headquartered in Marlborough.
Marlborough-based Sunovion Pharmaceuticals will seek regulatory approval for a new, quick-acting treatment of chronic obstructive pulmonary disease, after a final human trial reported positive results.
Last week, the company announced positive results of the final human trial of a long-acting medicine combined with an investigational nebulizer system called eFlow, which delivers a dose of medicine in two to three minutes. The study found SUN-101/eFlow, which refers to the combination of the two products, was well-tolerated as a twice-daily maintenance treatment for difficulty breathing in people with moderate-to-very severe chronic obstructive pulmonary disease.
The plan is to advance SUN-101/eFlow through the regulatory process as the first nebulized long-acting antagonist for patient use, according to Sunovion. The company said it anticipates it will file a new drug application for SUN-101/eFlow to the U.S. Food and Drug Administration at some point this year.
Dr. Nicola Hanania, associate professor at Baylor College of Medicine, said that if approved, SUN-101/eFLow could be transformative for patients with chronic obstructive pulmonary disease.
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