La Jolla Pharmaceutical scores FDA approval for blood pressure treatment
The FDA has announced that it has approved La Jolla Pharmaceutical’s Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure as a treatment for septic or other distributive shock – conditions caused when blood pressure drops to a point that major organs such as the brain and kidneys do not receive enough blood flow to adequately function.
The US regulator’s decision was based on data generated from a clinical trial of 321 participants which showed that “significantly more” patients responded to Giapreza than placebo, with the drug effectively increasing blood pressure when used in combination with other treatments for the condition.
“Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death,” explained Norman Stockbridge, Director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies.”
John A Kellum, Director of Center for Critical Care Nephrology, Vice Chair for Research, and Professor of Critical Care Medicine, University of Pittsburgh, added: “Vasopressors are critical to treat patients with shock. The critical care community now has another tool to use. The approval of angiotensin II represents a major advance in the treatment of patients with septic or distributive shock.”
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