Leaders in Pharmaceutical Business Intelligence (LPBI) Group

FDA Approves La Jolla’s Angiotensin 2

Reporter: Irina Robu, PhD

In La Jolla Pharmaceutical Company’s new drug application (NDA) for angiotensin 2, the treatment was given priority review status by the FDA, advancing the application process to 6 months. The US Food and Drug Administration has approved an IV agent to treat critically-low blood pressure angiotensin 2 injection (Giapreza) for the treatment of adults with septic or other distributive shock. The intravenous infusion therapy is considered to increase blood pressure in adult patients with hypotension. The condition can cause shock in which the brain, kidneys, and other vital organs are no longer getting the appropriate amount of blood flow to function correctly.

The trial was based on the 321-patient ATHOS-3 trial, in which 69.9% of patients with catecholamine-resistant hypotension treated with angiotensin II upgrading at hour 3 versus 23.4% with placebo. The exploratory therapy was run in combination with conventional treatments used to raise patients’ blood pressure. The treatment was revealed an increase blood pressure, reported safety and tolerability.

Even though the label indicates that the drug can cause thrombosis, concurrent prophylactic treatment should be used. In ATHOS-3, the incidence of arterial and venous thrombotic events was 13%, compared with 5% in the placebo group, mainly driven by deep vein thrombosis.

John A. Kellum, Director of Center for Critical Care Nephrology, University of Pittsburgh, said the treatment is now an additional tool for the critical care community.

SOURCE

https://www.medpagetoday.com/criticalcare/sepsis/70061