FDA approves potential lung drug, plecanatide, to treat some patients with pulmonary fibrosis

Federal health officials have found that a pill made by Merck can be used as a possible treatment to help treat patients suffering from pulmonary fibrosis, or scarring of the lungs, the company announced Thursday.

The Food and Drug Administration made the announcement at an FDA-sponsored advisory committee meeting in Colorado. Merck, along with University of Colorado Hospital and National Jewish Health, is studying the drug, plecanatide, to treat patients with the debilitating condition.

“The data are not strong enough for us to want to change our label,” Merck representative Laura Fulton told the advisory committee, according to a Reuters report.

Although physicians should not rely on this updated label, some of the advisory committee members seemed to express concern about the increased risk of heart attacks associated with the drug.

Pfizer and GlaxoSmithKline previously announced the results of a similar study. In March of last year, doctors presented data from a study that showed plecanatide reduced breathing difficulties from pulmonary fibrosis by 29 percent in patients with some form of the disease. This amount of improvement in breathing abilities has been likened to the decline in lung function experienced by people with lung cancer.

Because plecanatide is a new therapy, the FDA cautioned patients to take it with caution. The new label is only advisory and the federal agency could later make a more specific label decision.

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