FDA Priority Review on La Jolla Hypotension Drug

FDA has accepted for priority review a La Jolla Pharmaceutical Co. NDA for the investigational drug LJPC-501 (angiotensin II) for treating hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The agency has set a user fee review action target of 2/28/2018.

LJPC-501 is La Jolla’s proprietary formulation of synthetic human angiotensin II, a major bioactive component of the renin-angiotensin-aldosterone system, which is one of three central regulators of blood pressure, according to the company. The submission is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) Phase 3 clinical study in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The study was conducted under a Special Protocol Assessment agreed to with FDA in 2015, it says.