EMA’s CHMP Recommends New Use for GSK’s PAH DrugBy
GlaxoSmithKline (GSK) reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH). PAH is a disease characterized by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures.
The positive opinion is a formal recommendation by the CHMP to expand the existing marketing authorization for ambrisentan to include combination treatment. A final decision from the European Commission is anticipated by December 2015. Further regulatory submissions to include additional data in the ambrisentan label are ongoing and planned in other countries.
Ambrisentan, a selective endothelin type-A receptor antagonist, is approved in the European Union and other countries as a once-daily treatment for PAH, (WHO Group 1) in patients with WHO/NYHA functional class II and III symptoms. GSK commercializes ambrisentan under the tradename Volibris in territories outside of the United States, and Gilead commercializes ambrisentan under the tradename Letairis in the US.. Ambrisentan has been granted orphan drug status for the treatment of PAH in Australia, Europe, Japan, Korea, and United States.