Gilead Sciences is removing the potential liver damage warning currently on the label of Letairis, its pulmonary arterial hypertension treatment.
The biotechnology company is reporting that after reviewing post-market data on the drug’s use, the Federal Drug Administration has approved the removal of the warning, which means patients taking the drug will no longer have to take monthly liver function tests.
“This change will be tremendously helpful to both patients and the staff of specialist centers who diligently support them,” said Ronald J. Oudiz, MD, professor of medicine at the David Geffen School of Medicine at UCLA and director of the Liu Center for Pulmonary Hypertension at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. “Pulmonary arterial hypertension is a very complex disease at the best of times, so any steps to simplify care will be warmly welcomed.”
According to the National Heart Lung and Blood Institute, patients who suffer from PAH experience shortness of breath, tiredness, chest pain and racing heartbeats, making it difficult to exercise or even walk up flights of stairs. in more severe cases it can lead to heart failure.
Letairis treats high blood pressure and helps to improve patient’s ability to exercise, slowing down the physical conditions or symptoms related to PAH.