GSK Receives EC Expanded Indication for PAH Drug

The European Commission has granted an expanded approval to British drug giant GlaxoSmithKline’s Volibris to include its use in combination treatment for patients with pulmonary arterial hypertension. The drug is indicated for treatment of PAH in adult patients of WHO Functional Class II to III.

The expanded approval is based on data from the Phase 3b/4 AMBITION study, in which Volibris (ambrisentan) in combination with tadalafil reduced the risk of clinical failure by 50 percent in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy.

AMBITION was cosponsored by GSK and Gilead Sciences, with support provided by Eli Lilly. Gilead commercializes ambrisentan under the tradename Letairis in the U.S. GSK has rights to the product in other markets.

Further regulatory submissions are planned in other countries, GSK says. In early October, the FDA approved the use of Letairis in combination with tadalafil for the treatment of pulmonary arterial hypertension (WHO Group 1) to reduce the risks of disease progression and to improve exercise ability.