FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a change to the prescribing information for Letairis^® (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms. This change removes language concerning the potential risk of liver injury from the Boxed Warning. In conjunction with this label update, PAH patients receiving Letairis are no longer required to obtain monthly liver function tests.

“This change will be tremendously helpful to both patients and the staff of specialist centers who diligently support them. Pulmonary arterial hypertension is a very complex disease at the best of times, so any steps to simplify care will be warmly welcomed.”

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, which were 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 percent on Letairis and 2.3 percent on placebo.

"I am encouraged by these post-marketing data, which reflect the use of ambrisentan since its approval in 2007. These data are consistent with the results we have observed in controlled studies," said Ronald J. Oudiz, MD, Professor of Medicine, David Geffen School of Medicine at UCLA and Director, Liu Center for Pulmonary Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. "This change will be tremendously helpful to both patients and the staff of specialist centers who diligently support them. Pulmonary arterial hypertension is a very complex disease at the best of times, so any steps to simplify care will be warmly welcomed."

Gilead will continue to offer the full services of LabSync, which manages the administrative requirements associated with laboratory testing, to all patients enrolled in LEAP.