EU approves combination treatment Volibris (ambrisentan) and Adcirca (tadalafil) for pulmonary arterial hypertension- Glaxo Smith Kline/Gilead/Eli Lilly

The European Commission has approved a variation to expand the current therapeutic indication for Volibris (ambrisentan), from Glaxo Smith Kline/Gilead, to include its use in combination treatment with Adcirca (tadalafil), from Eli Lilly, for patients with pulmonary arterial hypertension (PAH). Volibris is indicated for treatment of PAH in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.

EU approval was based on data from the Phase IIIb/IV AMBITION study, which showed that the combination of ambrisentan and tadalafil reduced the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy. AMBITION was the first and only outcomes study to compare the efficacy and safety of investigational first-line combination therapy of ambrisentan and tadalafil to first-line monotherapy of either treatment alone in treatment-naïve patients with PAH. AMBITION was co-sponsored by GSK and Gilead, with support provided by Eli Lilly. Further regulatory submissions to include the AMBITION data in the ambrisentan label are ongoing and planned in other countries.

Comment: Actelion dominates the US market for PAH with Tracleer (bosentan). The medicine will be going off-patent in the next couple of years, but Actelion has already launched its follow-up, Opsumit (macitentan).