FDA Approves COPD Drug Opposed by Advisory Panel

The US Food and Drug Administration (FDA) has approved a new, once-a-day drug to treat chronic obstructive pulmonary disease (COPD) that was previously opposed by an advisory panel of outside experts on grounds of safety and efficacy.

The drug, roflumilast (Daliresp), is the first FDA-approved drug that inhibits an enzyme called phosphodiesterase type 4, which proved to be safe and effective in two phase 3 clinical trials involving more than 1,500 patients aged 40 years and older. It 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.

However, the FDA’s pulmonary-allergy drug advisory committee had previously voted 10 to 5 against the drug going on the market on the grounds that 14 percent of patients who took the drug discontinued it due to side effects. These side effects included diarrhea, nausea, weight loss and adverse psychiatric events, including three suicides and two suicide attempts. The incidence of cancer was also higher among patients taking roflumilast compared with those taking a placebo.

The panel concluded that the risks of the drug outweighed what the FDA found to be a “modest” increase in lung function. However, the drug was approved, as the recommendations of the FDA advisory committees are not binding on the agency. In its approval, the FDA is requiring that a medication guide be included with the drug that informs patients of the potential risks.

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