Evo Magz v4.7

a lung condition thats one of the biggest killers in the nation—now have a new treatment option: a once-a-day pill called Daliresp (roflumilast).

The U.S. Food and Drug Administration (FDA) approved the drug in March 2011. But the process was not smooth sailing. In 2010, an FDA advisory panel recommended against approving the drug. Even though the FDA almost always follows the advice of such expert panels, the agency went ahead and gave Daliresp a thumbs up anyway.

So should COPD patients be worried about taking the drug? No, says FDA spokesperson Morgan Liscinsky. According to Liscinsky, even though the FDA panel recommended against the drugs approval, "the final 10-to-5 vote by the advisory committee does not fully describe how the committee members viewed the evidence to support the safety and efficacy of roflumilast."

On separate questions, the panel had actually voted 9-to-6 in favor of adequate demonstration of efficacy (meaning that the studies suggested that the drug actually worked) and, again, 9-to-6 in favor of adequate demonstration of safety, says Liscinsky. "There was considerable positive opinion regarding its safety or efficacy."

But the committee had been asked to vote on a broader indication for the "maintenance treatment of COPD," which Liscinsky says the data did not support, rather than a more narrow use for treating the symptoms of exacerbations. Exacerbations are periods when COPD symptoms, such as shortness of breath and coughing, can get much worse due to an infection or other problem, and patients can wind up in the hospital.

Another major issue that held the panel back from giving the drug its blessing was that the group had to vote on whether it should be approved for a larger group of COPD patients. “People with mild disease could have been included in the [advisory committees] vote, and thats the major difference,” says Stephen Rennard, MD, a professor of medicine at the University of Nebraska Medical Center, in Omaha. Dr. Rennard is also a consultant to Forest Laboratories and Nycomed, the U.S. and European/Canadian companies, respectively, that own the license for roflumilast.