Gilead gets US FDA approval for hypertension drug Letairis
The US Food and Drug Administration (FDA) has granted approval of Letairis (ambrisentan) 5 mg and 10 mg tablets, developed by California-based biopharmaceutical company Gilead.
The US Food and Drug Administration (FDA) has granted approval of Letairis (ambrisentan) 5 mg and 10 mg tablets, developed by California-based biopharmaceutical company Gilead.
Letairis is an endothelin receptor antagonist (ERA) indicated for the once-daily treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO Functional Class II or III symptoms to improve exercise capacity and delay clinical worsening.
Because of the risks of liver injury and birth defects, the product will be available through the Letairis Education and Access Program (LEAP), a restricted distribution program designed to help patients learn about the risks of Letairis.
PAH is a debilitating and life-threatening disease for which there remains a significant need for new treatments,. said Lewis J. Rubin, Professor of Medicine, University of California, San Diego. "The availability of new treatments such as ambrisentan is critical to our ability to help patients living with this serious disease."