GlaxoSmithKline pulmonary hypertension drug Volibris enlargement adaptation has been approved by the European Union

December 1, 2015 - British pharmaceutical giant GlaxoSmithKline (GSK) recently announced that the European Commission (EC) has approved the expansion of Volibris (ambrisentan, Ambersontan) current therapeutic adaptation to include combination therapy for the treatment of patients with pulmonary hypertension (PAH). Volibris is suitable for the treatment of adult patients with pulmonary hypertension (PAH) in WHO Functional Classification II-III, including for combined therapy options. This approval will bring significant progress to future PAH clinical management and the prognostic prognostics of PAH patients.
approval is based on data from the IIIb/IV AMBITION study. The study showed that the combination therapy of Volibris and talafail significantly reduced the risk of clinical failure in patients with primary PAH by 50 per cent compared to Volibris monotherapy and other tadalafil monotherapy, with statistically significant differences (p<0.001).
It's worth noting that the AMBITION study is the first and only prognosis study to compare the safety and efficacy of experimental first-line combination therapies (Volibris plus tadaraf) and Volibris monotherapy and his Dara non-monotherapy therapy in the primary PAH population. The AMBITION study was conducted jointly by GlaxoSmithKline and Gilead and has traditionally been supported. In other countries, further regulatory submissions to incorporate AMBITION research data into Volibris drug labelling are currently under way and planned.
ambrisentan is a selective endotin A-type patient antagonist approved by the European Union and other countries as a daily drug for patients with pulmonary hypertension with WHO/NYHA functional grading II-III symptoms. In the U.S., ambrisentan's products are called Leitairis, sold by Gilead, and outside the U.S., ambrisentan's products are called Volibris and sold by GlaxoSmithKline. In the United States, Europe, Australia, South Korea, and Japan, ambrisentan has been granted orphan drug status.
Pulmonary Hypertension (PAH) is a rare disease with a global incidence rate of only 15 to 50 parts per million, characterized by abnormally elevated pulmonary blood pressure, a chronic, extremely severe and fatal disease characterized by shortness of breath, fatigue, fainting, chest pain, and leg and ankle edema. In addition, the patient's pulmonary hypertension will gradually increase, and even shorten the life span. (Bio Valley)