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# FDA Priority Review on La Jolla Hypotension Drug
- URL: https://www.fdaweb.com/fda-priority-review-on-la-jolla-hypotension-drug/
- Published: 2017-08-28T12:00:00.000Z
- Updated: 2026-09-14T22:44:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139485

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.