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FDA approves Daxas for Severe COPD

Posted Mar 03 2011 1:55am

The drug is not for patients with emphysema.  There are some side effects and they occur within the first week.  The drug is for long term treatment.  The drug targets image inflammation to improve lung functions.  BD 

FDA approved the first-and-only selective phosphodiesterase type 4 (PDE-4) inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD that involves primary emphysema.

Last April, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10 to 5 that safety and efficacy data were not strong enough to approve the drug as maintenance treatment for COPD patients with chronic bronchitis who are at risk of exacerbations, MedPage Today reported. Among patients taking roflumilast in clinical trials, 14% discontinued the drug because of side effects that included weight loss, psychiatric events including suicide, and the potential for cancer.

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