Gilead Sciences, Foster City, Calif, obtained FDA approval for its Letairis (ambrisentan) brand in 5 mg and 10 mg tablets for the once-daily treatment of pulmonary arterial hypertension (PAH).
PAH is a progressive, life-threatening disease that causes the pressure in a patient’s pulmonary artery to rise to dangerously high levels, putting strain on the heart.
“The availability of new treatments such as ambrisentan is critical to our ability to help patients living with this serious disease,” said Lewis J. Rubin, MD, professor of medicine at the University of California, San Diego.
Data from two long-term studies of ambrisentan—an endothelin receptor antagonist—showed that improvements in walk-distance upheld during a previously reported 12-week period were maintained for at least 48 weeks. The drug was also shown to prevent a clinical worsening of PAH.
Due to the risk of liver damage and birth defects, Letairis will be available for PAH patients in the United States early next week through the Letairis Education and Access Program before formulary status and payer coverage levels are finalized.
“Just ten years ago, patients had few options available to combat their disease, but there is now an emerging sense of hope as awareness of this important disease grows and new treatments become available,” said Rino Aldrighetti, president and CEO of the Pulmonary Hypertension Association.