GlaxoSmithKline has announced that it will be seeking new approval for its hypertension drug Volibris to be approved in Europe in an expanded capacity.
A regulatory submission has been filed with the European Medicines Agency for a variation to the marketing authorisation for Volibris, allowing it to be used in initial combination therapy for patients with pulmonary arterial hypertension.
“GlaxoSmithKline has filed for European approval of an expanded indication for Volibris in pulmonary arterial hypertension.“
This follows the completion of the recent phase IIIb/IV Ambition study, which demonstrated the benefits of combining Volibris and tadalafil in treatment-naive pulmonary arterial hypertension patients with World Health Organization functional class II and III symptoms.
Further regulatory submissions are planned in other countries over the remainder of 2014 and 2015.
Dr Carlo Russo, senior vice-president and head of GlaxoSmithKline rare diseases research and development, said: "This submission has been part of our efforts to continue to help patients with pulmonary arterial hypertension and we look forward to the outcome."
This comes after the company filed for European regulatory approval of an additional indication for the drug Revolade as a treatment for severe aplastic anaemia last month.See all the latest jobs in Pharmaceutical