FDA Approves COPD Drug Opposed by Advisory Panel

March 01, 2011

March 1, 2011 — The US Food and Drug Administration (FDA) announced today that it has approved a new, once-a-day drug to treat chronic obstructive pulmonary disease (COPD), even though an agency advisory panel of outside experts had opposed it on safety and efficacy grounds.

The new drug, roflumilast (Daliresp, Forest Laboratories), is indicated for people with severe COPD to prevent symptoms such as coughing and excess mucus from worsening, and to decrease the frequency of life-threatening COPD flare-ups. It should not be used to treat acute bronchospams.

The drug also is not intended for people whose COPD involves primary emphysema, nor is it recommended for patients younger than 18 years, according to the FDA.

The most commonly reported adverse effects include diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Last summer, the European Commission approved roflumilast as a supplement to bronchodilator therapy for severe COPD associated with chronic bronchitis in adults prone to frequent flare-ups.

Roflumilast represents the first FDA-approved drug in a class that inhibits an enzyme called phosphodiesterase type 4. The FDA said that it proved to be safe and effective in 2 phase 3 clinical trials involving more than 1500 patients aged 40 years and older.

However, in April 2010 the agency's pulmonary-allergy drugs advisory committee voted 10 to 5 against roflumilast going on the market. That vote reflected clinical trial data showing that 14% of patients who took the drug discontinued it because of diarrhea, nausea, weight loss, and psychiatric adverse events, including 3 suicides and 2 suicide attempts. The incidence of cancer was also higher among patients taking roflumilast compared with those taking a placebo.

In short, the panel concluded that the risks of roflumilast outweighed what the FDA characterized as a "modest" increase in lung function. However, the recommendations of FDA advisory committees are not binding on the agency.

In its approval of the drug, the FDA is requiring a medication guide that informs patients of the potential risks of psychiatric adverse effects, as well as unexplained weight loss.

More information on roflumilast is available on the FDA Web site.


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