TGA approves combination treatment for PAH treatment

Australian regulator the TherapeuticGoodsAdministration(TGA)hasapproveda variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment with tadalafil for patients with pulmonary arterial hypertension (PAH) in Australia.

Volibris, from UK pharma major GlaxoSmithKline (LSE: GSK), is indicated as monotherapy for the treatment of idiopathic PAH and PAH associated with connective tissue disease in patients with WHO functional class II, III and IV symptoms and is now indicated in combination with tadalafil, (Adcirca from Eli Lilly)for the treatment of WHO Group 1 PAH in patients with WHO functional class II, III or IV symptoms. The combination treatment received backing from the European Commission last year (The Pharma Letter November 24, 2015).

In a report last year on the use of combination therapies for PAH, GlobalData said it believes that the only deterrent to altering the standard course of treatment could be financial pressures from health care insurers, as the average annual cost of therapy for PAH treatment is already around $130,000 (TPL October 1, 2015).