GSK Files MAA For Volibris To Treat PAH In EU

GlaxoSmithKline reported that it has filed a variation of Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its drug Volibris (ambrisentan) to include pulmonary arterial hypertension (PAH) in its indication as a combination treatment.

Volibris is a selective endothelin type-A receptor antagonist currently authorized in the EU for adults with PAH classified as WHO functional class II and III. The drug is indicated to improve exercise capacity in this patient group. It has also been designated as orphan drug for the treatment of PAH in Japan, Korea, U.S., EU, and Australia. GSK markets Volibris outside the U.S., while its partner Gilead Sciences markets ambrisentan as Letairis in the U.S.

The company’s application with the EMA is supported by positive results from the Phase 3B/4 AMBITION study investigating the combination therapy of ambrisentan and tadalafil for PAH patients with WHO functional class II and III symptoms and who have not undergone previous treatment. The study was also conducted in collaboration with Gilead.

Dr. Carlo Russo, SVP, Head of GSK Rare Diseases R&D, said, “We hope that evidence from the AMBITION study, which showed that starting initial combination of ambrisentan and tadalafil was superior to first-line monotherapy with either medicine alone, will help support the management of patients who suffer with this rare and debilitating lung disease.”

In patients with pulmonary arterial hypertension, blood vessel constriction in the lungs leads to elevated pulmonary arterial pressures, in turn hindering the heart’s ability to pump blood efficiently and causing affected patents to suffer from shortness of breath and ultimately to succumb to heart failure. PAH afflicts an estimated 200,000 people around the world.

GlaxoSmithKline said it plans to file further regulatory applications for Volibris in other countries this year through 2015.

The company’s latest approval in the EU was Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL). GSK filed the Marketing Authorization Application (MAA) for Arzerra together with its partner Genmab.