The Food and Drug Administration said a proposed lung drug that would be marketed by Forest Laboratories Inc. (FRX) to treat chronic obstructive pulmonary disease was effective, but raised concerns about potential heart problems.
Forest is seeking FDA approval for aclidinium bromide, a long-acting inhaled drug developed for the treatment of COPD. Forest licensed the U.S. rights for the product from Almirall S.A. (ALM.MC). Aclidinium will be reviewed on Thursday by FDA's pulmonary allergy drugs advisory panel, which is made up of non-FDA medical experts. The FDA released a review of aclidinium on Tuesday in preparation for the meeting.
The agency said three clinical studies of the drug showed it was effective at increasing airflow through the lungs compared to patients receiving a placebo, or inactive drug. FDA's safety review focused on cardiovascular risks because of concerns previously raised about other drugs in the same class. FDA said there was an "apparent imbalance" in cardiovascular deaths among patients treated with aclidinium compared to those not receiving the drug. There were four cardiovascular deaths among patients receiving a 400 microgram dose of the drug, but FDA said that event rate was lower than what is typically seen among COPD patients.
"It is difficult to dismiss the apparent imbalance in cardiovascular deaths between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal," FDA said.
There is just one other long-acting drug for COPD, Spiriva, co-marketed by Boehringer Ingelheim GMBH and Pfizer Inc. (PFE), that is in the same class as aclidinium. Aclidinium, however, is designed to work in a different manner than Spiriva to keep airways open. In 2008, FDA started a safety review of Spiriva after receiving information from clinical studies that suggested the product might be associated with a higher stroke risk. But in 2010 the FDA cleared Spiriva of increasing stroke or heart problems.
FDA will ask the panel to discuss whether clinical trials involving aclidinium were large enough and long enough to address safety questions. The panel will also be asked to vote on a series of questions about whether it thinks the product is safe and effective and whether it thinks the product should be approved. The FDA will make the final decision about whether to approve aclidinium but usually follows its panel recommendations.
Forest, in a document posted to FDA's website Tuesday, said aclidinium "will provide an important additional...treatment option with demonstrated efficacy and safety."
According to the National Institutes of Health, chronic obstructive pulmonary disease, marked by damaged lungs, is the fourth leading cause of death in the U.S., and is primarily caused by smoking. The disease causes the lungs' airways to become partly obstructed, making it difficult to breathe.
--By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; firstname.lastname@example.org