Daxas® (Roflumilast)

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 marketed from the second quarter 2011 by Nycomed’s US partner Forest Laboratories under the brand name Daliresp™.

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

25 September 2011: New data analysis supports the use of Daxas
9 June 2011: Forest Laboratories, Inc. Announces Availability of Daliresp(TM) in US Pharmacies from mid-June 2011
5 May 2011: Nycomed and Almirall announce commercialization agreement for roflumilast in Spain
30 March 2011: Nycomed announces REACT study to evaluate impact of Daxas® (roflumilast) in patients receiving standard COPD treatment
1 March 2011: Nycomed’s novel COPD therapy roflumilast receives FDA approval
6 January 2011: Daxas® (Roflumilast) included as a new treatment option in latest international COPD guidelines
13 September 2010 Nycomed's US partner Forest Laboratories responds to FDA complete response letter
1 September 2010: From Oranienburg to the rest of the world: global market launch of Daxas® (roflumilast) kicks off in Germany
6 July 2010: Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) receives marketing authorisation in the European Union for patients with COPD
May 2010: Nycomed and Forest Laboratories receive complete FDA response letter for Roflumilast
April 2010: Nycomed and Merck Co Inc announce commercialization agreements for Daxas in Europe and Canada
April 2010: CHMP recommends approval of Daxas in European Union
September 2009: Roflumilast data presented at ERS 2009
August 2009: Four studies published in The Lancet show roflumilast Daxas
August 2009: Nycomed and Forest Laboratories to collaborate on US commercialisation of Daxas in COPD
July 2009: Nycomed announces FDA filing for Daxas in COPD
May 2009: Nycomed files European marketing authorisation application for Daxas in COPD
October 2008: Nycomed's Daxas shows encouraging preliminary results