Nycomed has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas (roflumilast) in the European Union. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD.
Daxas is recommended for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50 per cent predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. With the granting of the marketing authorisation by the European Commission, Daxas, a once-a-day tablet, would become the first drug in a new class. Daxas is expected to be launched in the first European countries later this year.
Commenting on this announcement, Anders Ullman, executive vice president Research and Development at Nycomed, said, "Nycomed is excited about the positive opinion of the CHMP recommending approval of Daxas in the European Union. Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much needed new treatment option alongside existing inhaled therapies."
The application to the EMA was based on encouraging results from four phase-III trials of roflumilast in the treatment of symptomatic COPD. In two pivotal placebo controlled, 12-month studies involving a total of over 3,000 patients with COPD, roflumilast demonstrated statistically significant improvements on both co-primary endpoints; moderate to severe exacerbations and pre-bronchodilator FEV1. The effect of Daxas was independent of concomitant use of long-acting beta2-agonist (LABA)1. Roflumilast also demonstrated a statistically significant improvement compared to placebo on lung function, in two supportive studies over a six month period when added to the commonly used long-acting bronchodilators tiotropium or salmeterol.
Full data from all four studies were published in The Lancet in August 20091,2 and were presented at the annual European Respiratory Society (ERS) Congress in Vienna, Austria, in September 2009.
Nycomed submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) in July 2009 and has signed a collaboration and distribution agreement for Daxas in the US with Forest Laboratories, Inc. in August 2009.
Daxas (roflumilast) is an orally administered selective phosphodiesterase 4 (PDE4) enzyme inhibitor, which has been shown to inhibit COPD related inflammation with a novel mode of action.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.