ZURICH, Switzerland Nycomed announced it has submitted a new drug application to the Food and Drug Administration for Daxas, a once-daily treatment of symptomatic chronic obstructive pulmonary disease.
The decision for the NDA submission was made after the successful results from four Phase three trials.
In addition, Nycomed completed the submission of a marketing authorization application to the European Medicines Agency for Daxas as a once-daily oral treatment for patients with symptomatic COPD. The filing is currently under regulatory review.
According to World Health Organization, approximately 80 million people suffer from moderate to severe COPD worldwide. Additionally, WHO predicts the total death rate resulting from the medical condition could increase by more than 30% in the next 10 years unless immediate action is taken to reduce the underlying risk factors, especially smoking.