Product description: 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. Daxas®, a once-a-day oral tablet, is the first drug in a new class of treatment for COPD and the first oral anti-inflammatory treatment for COPD patients. Other pharmacological treatments for COPD patients include the use of inhaled bronchodilators and inhaled corticosteroids.
Daxas® has been launched in a number of European countries. In some markets, it will be jointly marketed by Nycomed and MSD (known in the US and Canada as Merck & Co., Inc.)
In the United States, roflumilast has been approved by the US Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It will be available from mid-June 2011 by Nycomed’s US partner Forest Laboratories under the brand name Daliresp™.
Medical need: COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterized by severe episodes of worsening, called exacerbations. According to World Health Organization (WHO) estimates, 210 million people have COPD worldwide. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.
Think COPDifferently (Nycomed information site for european medical professionals only)
WHO Facts on COPD
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