Nycomed Submits New Drug Application To FDA For Daxas

Nycomed has submitted a New Drug Application (NDA) to the FDA for Daxas, as a once-daily oral treatment for patients with symptomatic COPD.

The NDA submission is based on encouraging results from four phase III trials of Daxas (roflumilast), in the treatment of symptomatic COPD, said the company.

Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV1). Two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments.

Nycomed has also completed the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas, as a once-daily oral treatment for patients with symptomatic COPD. The filing is currently under regulatory review.

Hakan Bjorklund, CEO of Nycomed, said: With its novel mode of action, Daxas represents an important new approach to the management of COPD – a disease which is predicted to become the third leading cause of death worldwide by 2030. The FDA filing, which follows the submission of Daxas to the EMEA in May, is another important step for Daxas in the key US market. Discussions with potential US commercialisation partners are now well advanced.