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Roflumilast Approved in Europe for Chronic Obstructive Pulmonary Disease

Posted Jul 21 2010 10:06am

The European Commission (EC) has approved roflumilast once-daily tablets (Daxas; Nycomed, Inc) as an add-on to bronchodilator therapy for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adults with a history of frequent exacerbations.

Roflumilast is a phosphodiesterase-4 inhibitor and represents a new molecular entity — the first new drug class to be approved for patients with COPD in more than 10 years.

“Daxas…has a unique mode of action which targets the underlying inflammation in COPD and is an important addition to the current options available to doctors and patients,” stated Klaus F. Rabe, MD, from the University Medical Centre Leiden, the Netherlands, in a company news release.

As the first oral anti-inflammatory to be approved for COPD, roflumilast may fill a therapeutic gap for patients with frequent exacerbations.

“There are still huge unmet needs when it comes to the medical care of patients with COPD, both in terms of just symptomatic relief — in terms of bronchodilation — but also particularly in terms of exacerbation prevention,” said Andrew F. Shorr, MD, MPH, FCCP, in an interview with Medscape Medical News, noting that exacerbations are associated with substantial morbidity and mortality and lead to an accelerated decline of patient functioning.

This Article is available in it’s entirety at Medscape Today.


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