The change removes language from the boxed warnings concerning the potential risk of liver injury. In conjunction with the label update, PAH patients taking Letairis are no longer required to obtain monthly liver function tests.
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“I am encouraged by these post-marketing data, which reflect the use of ambrisentan since its approval in 2007,” said Dr. Ronald Oudiz, director of the Liu Center for Pulmonary Hypertension at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center in a statement. “These data are consistent with the results we have observed in controlled studies.”
The FDA approved the new labeling based on its review of post-marketing data reflecting use of Letairis over more than 7,800 patient years. During the 12-week controlled clinical trials, there were no incidents of liver function abnormalities, and 2.3% on placebo.