Nycomed has submitted a marketing authorization application to the European Medicines Agency for Daxas as a once-daily oral treatment for patients with chronic obstructive pulmonary disease associated with chronic bronchitis.
The marketing authorization application (MAA) submission is based on encouraging results from four Phase III trials of Daxas in the treatment of symptomatic chronic obstructive pulmonary disease (COPD).
Approximately two pivotal 12-month studies met their primary endpoints, showing effects on exacerbation rates and pulmonary function. Approximately two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. Full data from all four studies are to be reported during 2009.
Nycomed is also preparing for the submission of a new drug application to the FDA for Daxas as a once-daily oral treatment for patients with COPD associated with chronic bronchitis.
Hakan Bjorklund, CEO of Nycomed said: With its novel mode of action, Daxas represents a potentially important new approach in the management of COPD. The Daxas submission, subject to acceptance and approval by the European Medicines Agency, represents a significant milestone for Nycomed. Our search for a US partner is on track, and we will submit a regulatory filing to the FDA soon.