Letairis Combo Nabs FDA Nod for Pulmonary Arterial Hypertension

The FDA has approved a new treatment combination of Gilead’s ambrisentan (Letairis) with tadalafil to treat pulmonary arterial hypertension.

The combination has been shown to reduce the risk of disease progression by nearly 50% compared with either treatment alone. The products are also designed to reduce the risk of hospitalization for worsening symptoms and to improve exercise ability.

The FDA based its approval decision on data from the AMBITION study, which was a randomized, double-blind, multicenter trial of 605 patients.

“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,” said Ronald Oudiz, director of the Liu Center for Pulmonary Hypertension at the Los Angeles Biomedical Research Institute, in a press release. “As such, this combination represents a new treatment strategy for patients living with this debilitating and life-threatening disease.”

Adverse effects of ambrisentan used in combination with tadalafil include headache, nasal congestion, cough, and anemia.

The combination treatment is not recommended for women who are breastfeeding or those who may be pregnant.

An earlier version of this article incorrectly identified Cialis as the brand-name tadalafil approved for this combination.