FDA Approves La Jolla's Angiotensin 2 for Septic Shock

The US Food and Drug Administration (FDA) has approved angiotensin 2 injection (Giapreza) for the treatment of adults with septic or other distributive shock.

The intravenous infusion therapy is designed to increase blood pressure in adult patients with hypotension, a condition in which a patient has significantly low blood pressure. The condition can cause shock — in which the brain, kidneys, and other vital organs are no longer receiving the appropriate amount of blood flow to function correctly.

Angiotensin 2 was proven beneficial in a 321-patient clinical trial, in which patients with shock and critically low blood pressure were treated with either the injection vasopressor therapy or placebo. The investigative therapy was administered in combination with other conventional treatments used to raise patients’ blood pressure.

A significantly greater rate of patients to receive angiotensin 2 responded to the combination therapy versus placebo. The treatment was shown to increase blood pressure, and reported safety and tolerability.

Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products for the FDA’s Center for Drug Evaluation and Research, said shock can commonly result in organ failure and death, giving weight to therapies being approved for hypotension.

“There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies,” Stockbridge said.

In La Jolla Pharmaceutical Company’s new drug application (NDA) for angiotensin 2, the therapy was given Priority Review status by the FDA, expediting the application process to 6 months.

John A. Kellum, MD, Director of Center for Critical Care Nephrology, Vice Chair for Research, and Professor of Critical Care Medicine, University of Pittsburgh, said the treatment is now another tool for the critical care community.

“The approval of angiotensin 2 represents a major advance in the treatment of patients with septic or distributive shock,” Kellum said.

La Jolla intends to deliver Giapreza to US markets starting in March 2018.