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Giapreza approved by FDA for treating dangerously low blood pressure

Giapreza (angiotensin II) injection is now approved for treatment of dangerously low blood pressure in adults with septic or other forms of distributive shock. The intravenous infusion gained US Food and Drug Administration (FDA) approval following a clinical trial of 321 patients with shock and a critically low blood pressure. 

The drug received approval under Priority Review, which enables the FDA to take action within six months on applications the agency considers could significantly improve the safety or effectiveness of treatment, diagnosis or prevention of a serious condition. Approval for Giapreza was granted to La Jolla Pharmaceutical Company, which aims to make the drug available for patients in the United States in March 2018. 

The United States has around 800,000 distributive shock cases each year, of which an estimated nine out of ten are septic shock patients. The current standard therapy does not achieve adequate blood pressure response in approximately 300,000 cases, which can result in inadequate blood flow to the organs and tissues. 

Distributive shock can have a number of causes, including (among others) sepsis, trauma, burns, toxic shock syndrome, anaphylaxis, and pancreatitis. Treatment depends on the cause of shock, but vasopressors and inotropes are often used. In cases of septic shock, patients are often treated with antimicrobial drugs to target the cause of the infection, while anaphylactic shock is treated with epinephrine. 

Angiotensin II causes vasoconstriction and an increase in blood pressure by stimulating a protein in the muscle cells. John A. Kellum, MD, director of Center for Critical Care Nephrology, vice chair for research, and professor of Critical Care Medicine at the University of Pittsburgh, explained: “Vasopressors are critical to treating patients with shock. The critical care community now has another tool to use.” He described the approval of angiotensin II as a “major advance” in the treatment of patients with septic or distributive shock. 

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