SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.
The FDA announced the approval of Daliresp (roflumilast), a daily pill designed to decrease the frequency of flare-ups or worsening of symptoms from severe COPD. The agency said the drug did not have a brand name at the time of approval, though Forest already had chosen one at the time of this writing. The drug is for people with severe COPD to treat the symptoms of cough and excess mucus linked with bronchitis, but not primary emphysema. COPD comprises both diseases.
“COPD is a serious disease that gets worse over time,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said. “New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease.”