GILEAD SUBMITS APPLICATION FOR ONCE-DAILY PAH TREATMENT

Gilead Sciences announced that the FDA has accepted for filing and granted priority review to its new drug application (NDA) for ambrisentan, 5 and 10 mg, for the once-daily treatment of pulmonary arterial hypertension (PAH).

Priority review status is assigned to a drug product that, if approved, would be a significant improvement over currently marketed products. The FDA goal for reviewing an NDA under priority review is six months, and the agency has established a target review date of June 18, 2007, Gilead said.

Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. Activation of the ETA receptor by endothelin, a small peptide hormone, leads to vasoconstriction and cell proliferation. PAH is associated with elevated endothelin blood levels. Ambrisentan has been granted orphan drug designation for the treatment of PAH in the U.S. and the European Union.

GlaxoSmithKline holds rights to commercialize ambrisentan in territories outside of the U.S.