The US Food and Drug Administration (FDA) has approved the use of ambrisentan (Letairis, Gilead Sciences) in combination with tadalafil (Cialis, Eli Lilly) as up-front therapy for pulmonary arterial hypertension (PAH) to reduce the risk of worsening disease and improve exercise ability, according to Gilead Sciences.
Ambrisentan is a selective endothelin type A receptor antagonist approved in 2007 in the United States as monotherapy for PAH. Tadalafil is a phosphodiesterase type 5 inhibitor approved for PAH in the United States in 2009.
“Based on the data supporting today’s approval, we now know that patients receiving ambrisentan and tadalafil up front are less likely to experience disease progression or be hospitalized, and have more improvement in exercise ability than patients receiving either effective therapy alone. As such, this combination represents a new treatment strategy for patients living with this debilitating and life-threatening disease,” said Ronald J. Oudiz, MD, director of the Liu Center for Pulmonary Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, in a company news release.
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