WASHINGTON--The Food and Drug Administration approved Monday a new lung drug designed to treat chronic obstructive pulmonary disease that will be marketed by Forest Laboratories Inc. (FRX). The drug, Tudorza Pressair, is a long-acting medicine that is delivered through an inhaler that helps muscles around the large airways of the lungs stay relaxed to improve airflow. Forest licensed the U.S. rights for the product from Almirall SA. (ALM.MC) The approval was expected after an FDA advisory panel voted to support the product at a February meeting. Chronic obstructive pulmonary disease, marked by damaged lungs, is the fourth-leading cause of death in the U.S., according to the National Institutes of Health. The disease, which is primarily caused by smoking, causes the lungs' airways to become partly obstructed, making it difficult to breathe. The FDA said three clinical studies of the Tudorza Pressair showed it was effective at increasing airflow through the lungs compared to patients receiving a placebo, or inactive drug. FDA's safety review of the product focused on cardiovascular risks because of concerns previously raised about the other long-acting drug in same class of medicines used to treat COPD, Spiriva, co-marketed by Boehringer Ingelheim GMBH and Pfizer Inc., (PFE). In 2008 the FDA started a safety review of Spiriva after receiving information from clinical studies that suggested the medicine might be associated with a higher stroke risk, but in 2010 the FDA cleared Spiriva of increasing stroke or heart problems. The FDA said Tudorza Pressair could cause serious side effects, including narrowing of the airways, increased pressure in the eyes or urinary retention. The agency said Tudorza Pressair should not be used as a short-term medication to treat an acute breathing problem and isn't recommended for people younger than 18 years old. Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com Subscribe to WSJ: http://online.wsj.com?mod=djnwires
