FDA Removes Hepatotoxicity Risk from Boxed Warning for Letairis

Gilead Sciences announced that the FDA has approved a change to the labeling for Letairis (ambrisentan tablets) that removes language from the Boxed Warning concerning the potential risk of liver injury. Patients receiving Letairis are no longer required to obtain monthly liver function tests. The new labeling was approved based on the FDA's review of post-marketing data reflecting use of Letairis over more than 7,800 patient years collected through the Letairis Education and Access Program (LEAP). These data were consistent with clinical trial data used to support the registration of Letairis. During 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo.

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in patients with WHO Class II or III symptoms to improve exercise ability and delay clinical worsening.

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