Forest Labs Get FDA COPD Risk Treatment Approval

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Approximately 12 million people in the United States are currently diagnosed with chronic obstructive pulmonary disorder (COPD), and an additional 12 million are likely to have the disease and not know. This week Daliresp (roflumilast) was approved by the US Food and Drug Administration (FDA) as a treatment to reduce the risk of disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.


COPD is caused by noxious particles or gas, most commonly from tobacco smoking, which triggers an abnormal inflammatory response in the lung. The inflammatory response in the larger airways is known as chronic bronchitis, which is diagnosed clinically when people regularly cough up sputum. In the alveoli, the inflammatory response causes destruction of the tissues of the lung, a process known as emphysema. The natural course of COPD is characterized by occasional sudden worsening of symptoms called acute exacerbations, most of which are caused by infections or air pollution.


The World Health Organization (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. Approximately half of COPD patients treated by a physician with controller medications have severe COPD. Of the patients diagnosed with severe COPD, almost three quarters, or 2.8 million, have chronic bronchitis.


COPD is projected to be the fourth leading cause of death worldwide by 2030 (an increase from sixth in 2009) due to an increase in smoking rates and demographic changes in many countries. COPD is the fourth leading cause of death in the U.S. and the economic burden of COPD in the U.S. in 2007 was $42.6 billion in health care costs and lost productivity.


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 or lung attacks.


Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.


Guido Oelkers, Executive Vice President, Commercial Operations at Nycomed, Forest's parent, said:


"Nycomed is very pleased with the US approval of Daliresp by the FDA. With Forest we have an ideal partner, who is absolutely committed to make this innovative treatment available in the United States for the many patients suffering from severe COPD. The approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies."



Roflumilast has been approved in the European Union and Canada in 2010 and it is marketed under the brand name Daxas. In February 2011 it received marketing authorisation from the Brazilian National Health Surveillance Agency (ANVISA). Daxas has been launched in several countries already, as for example Germany, Denmark, Sweden, UK, Canada and Spain. It is scheduled to be launched in other markets in 2011.


Professor Stephen Rennard, M.D., University of Nebraska Medical Center and clinical trial investigator continues:


"The introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Reducing the risk of COPD exacerbations is an important goal of COPD treatment."