The U.S. Food and Drug Administration approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or another distributive shock.
Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research said, “Shock, the inability to keep up blood flow to vital tissues, can result in organ failure and death”.
“There is a need for treatment options for critically sick hypotensive patients who don’t adequately respond to available treatments.”
Against the walls of the arteries, blood pressure is the force of blood pushing as the heart pumps out blood. Hypotension is abnormally low blood pressure. Shock is a critical condition in which blood pressure drops so low that the brain, kidneys and other vital organs can’t get enough blood flow to function properly.
In a clinical trial conducted in 321 patients with low blood pressure and shock, with Giapreza significantly more patients responded to treatment compared with those treated with placebo. Giapreza effectively increased blood pressure when added to conventional medicines used to raise blood pressure.
With serious consequences (clots in arteries and veins, including deep venous thrombosis), Giapreza can cause dangerous blood clots; prophylactic treatment for blood clots should be utilized. This application received a Priority Review, under which the FDA will probably make a move on an application inside a half year when the agency confirms that the medication if approved, would significantly improve the effectiveness or safety of treating, diagnosing or preventing a serious condition.
The FDA granted the approval of Giapreza to La Jolla Pharmaceutical Company. The FDA, an agency within the U.S. Department of Health and Human Services, promotes and ensures the public health by, in addition to other things, guaranteeing the safety, effectiveness, and security of human and veterinary medications, vaccines and other organic things for human use, and medical devices.
The agency also is responsible for the safety and security of our country’s food supply, beauty care products, dietary supplements, products that give off electronic radiation, and for controlling tobacco products.