28 August 2017 - Priority review granted.

La Jolla Pharmaceutical Company today announced that the U.S. FDA has accepted for review the Company’s new drug application for the investigational drug LJPC-501 (angiotensin II) for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. 

The review classification for the application is priority, and the user fee goal date under the Prescription Drug User Fee Act is 28 February 2018. In its letter to the Company, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application.

The application for LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The study was conducted under a Special Protocol Assessment (SPA) agreed to with the FDA in 2015.

Read La Jolla Pharmaceutical press release