Giapreza Approved to Treat Critically Ill Hypotensive Patients

This application received a Priority Review
This application received a Priority Review

The Food and Drug Administration (FDA) has approved Giapreza (angiotensin II intravenous infusion; La Jolla Pharmaceutical Company) to increase blood pressure in adult patients with septic or other distributive shock. 

The approval was based on the ATHOS-3 trial, a double-blind clinical study (n=321) of patients with shock and critically low blood pressure who remained hypotensive despite fluid or vasopressor therapy. The primary endpoint was the percentage of patients who achieved either a mean arterial pressure (MAP) ≥75mmHg or a ≥10mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours.

The data showed significantly more patients responded to Giapreza vs placebo and that Giapreza effectively increased blood pressure when added to standard treatments used to raise blood pressure. The primary endpoint was achieved in 70% of patients assigned to Giapreza vs 23% of patients assigned to placebo (P<0.0001); this translated to a treatment effect of 47%. 

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Giapreza, a vasoconstrictor, increases blood pressure through increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells, ultimately causing smooth muscle contraction.

Giapreza will be available as 2.5mg/mL and 5mg/2mL strength single-dose vials. It is anticipated to launch in March 2018.

For more information call (800) 651-3861 or visit Giapreza.com.