The drug, for pulmonary arterial hypertension, was approved by the European Medicines Agency.
GlaxoSmithKline’s Marketing Authorization Application (MAA) for ambrisentan for the treatment of pulmonary arterial hypertension (PAH) was validated by the European Medicines Agency following a review by the Committee for Medicinal Products for Human Use (CHMP). Following the validation of an MAA, the dossier is distributed to members of the CHMP for formal review. As a result of this validation, GlaxoSmithKline will pay Gilead Sciences an undisclosed milestone payment.
Under a prior agreement, GlaxoSmithKline holds rights to commercialize ambrisentan in territories outside of the U.S.
Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A receptor. It has been granted orphan drug designation for the treatment of PAH in both the U.S. and EU.
The FDA recently accepted for filing and granted a Priority Review for Gilead’s NDA for marketing approval of ambrisentan (5 mg and 10 mg) for the once-daily treatment of PAH. The FDA has established a target review date of June 18, 2007.