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.