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GSK earns expanded approval for Volibris in Europe

Additional indication given to pulmonary arterial hypertension drug

GlaxoSmithKline's pulmonary arterial hypertension drug Volibris has won expanded approval from the European Commission. 

But, the decision is based on data from the phase III/IV AMBITION study, which showed that the combination of Volibris (ambrisentan) and tadalafil reduced the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy.

Jonathan Langley, clinical investigation lead for PAH at GSK, said: “PAH is a rare, chronic and life-changing disease that can result in heart failure and death if left untreated.

“The AMBITION study has demonstrated that the early combination of two treatments that target different pathways in PAH can halve the risk of clinical failure and more than half the rate of hospitalisation for patients, compared to either treatment given individually.

“The expanded authorisation for Volibris will make an important difference to the future management of PAH and the outcomes of patients living with this highly debilitating condition.”

The expanded approval will come as good news for GSK, which is facing competition from other PAH drugs such as Actelion's Opsumit (macitentan) and Uptravi (selexipag) as well as Bayer's Adempas (riociguat) and United Therapeutics' Orenitram (trepostinil).

Analysts have predicted that the PAH market will grow at around 2.3% a year to 2020 with revenues growing from just over $4bn in 2013 to $5.2bn in 2020.

Article by
Nikhil Patel

26th November 2015

From: Regulatory



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