FDA staff focus on safety of Forest lung drug

Drug reviewers said Forest Laboratories Inc and Almirall SA’s inhaled lung treatment worked, but raised concerns about potential heart problems linked to drugs in the same class.

Food and Drug Administration staff said on Tuesday the drug, known generically as aclidinium bromide, reduced constriction of the lungs associated with chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult and is often caused by cigarette smoking. It is the fourth-leading cause of death in the United States and affects about 24 million people, according to the American Lung Association.

But the FDA reviewers said clinical trials may not have been big enough to show potential heart problems. Other drugs in the same class, known as anticholinergic drugs, have been tied to deaths related to heart issues.

In the clinical trials for Forest and Almirall’s lung drug, four patients taking the drug died from cardiac arrest and one from heart failure, out of a total of about 1,500 people who took the 400 mg dose of the inhaled powder.

“Whether these results represent a spurious finding or a potential safety signal is difficult to discern and may warrant further investigation,” the FDA staff said in documents posted online.

The FDA review comes ahead of an advisory panel on Thursday, which will vote on whether to recommend approval of the drug.

Shares of Forest, which has a licensing agreement with the Spanish drugmaker Almirall to market the drug in the United States, were largely flat at $32.05 in morning trading on the New York Stock Exchange.

Forest is counting on new treatments such as aclidinium to help prop up profits through a difficult period in the coming few years, as the top product that it markets in the United States, the antidepressant Lexapro, is expected to lose U.S. patent protection this year.

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By Anna Yukhananov

WASHINGTON