FDA Clears Angiotensin II (Giapreza) for Septic Shock

Megan Brooks

December 21, 2017

The US Food and Drug Administration (FDA) has approved angiotensin II injection for intravenous infusion (Giapreza, La Jolla Pharmaceutical Co) to increase blood pressure in adults with septic shock or other distributive shock, the agency announced December 21.

"Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death. There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies," Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

In a clinical trial of 321 patients with shock and critically low blood pressure, significantly more patients responded to treatment with the angiotensin II injection compared with those treated with placebo. "Giapreza effectively increased blood pressure when added to conventional treatments used to raise blood pressure," the FDA said.

The agency cautions that the drug can cause deep venous thrombosis and arterial thrombosis, and prophylactic treatment for blood clots "should be used."

Giapreza received priority review, a designation that speeds the review process and is granted when the FDA determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

Distributive shock results from excessive vasodilation and the impaired distribution of blood flow. Septic shock is the most common form of distributive shock and is characterized by considerable mortality (treated, around 30%; untreated, probably >80%). In the United States, septic shock is the leading cause of noncardiac death in intensive care units.

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