Gilead’s hypertension drug receives priority review from FDA

Priority review status is assigned to drug products that, if approved, would offer a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. The FDA’s goal for reviewing a drug with priority review is six months.

California-based Gilead submitted its new drug application for ambrisentan on December 18, 2006. The FDA has established a target review date of June 18, 2007. Ambrisentan has already been granted orphan drug designation for the treatment of pulmonary arterial hypertension (PAH) in both the US and in the EU.

PAH is characterized by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. Patients with PAH suffer from shortness of breath as the heart struggles to pump against these high pressures, causing such patients to ultimately die of heart failure.