FDA OKs Drug for Critically Low Blood Pressure in Septic Shock

Officials with the FDA have approved angiotensin II (Giapreza, La Jolla Pharmaceutical Company) injection for intravenous infusion to treat dangerously low blood pressure in adults with septic or other distributive shock, according to an FDA press release.¹

The approval is based on a clinical trial including 321 patients with shock and critically low blood pressure. According to the FDA, significantly more patients responded to treatment with angiotensin II than those treated with a placebo, and angiotensin II effectively increased blood pressure when added to conventional treatments used to raise blood pressure.

“Vasopressors are critical to treat patients with shock. The critical care community now has another tool to use,” John A. Kellum, MD, Director of Center for Critical Care Nephrology, Vice Chair for Research, and Professor of Critical Care Medicine at University of Pittsburgh said in a press release.² “The approval of angiotensin II represents a major advance in the treatment of patients with septic or distributive shock.”

Angiotensin II can cause dangerous blood clots with serious consequences. According to the press release, prophylactic treatment for blood clots should be used.

La Jolla expects to make Giapreza available for patients in the United States in March 2018.

Reference

• FDA approves drug to treat dangerously low blood pressure [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590249.htm. Accessed December 21, 2017.
• La Jolla Pharmaceutical Company Announces FDA Approval of Giapreza™ (angiotensin II) [news release]. San Diego. La Jolla’s website. http://ir.lajollapharmaceutical.com/phoenix.zhtml?c=102516&p=irol-newsArticle&ID=2323899. Accessed December 21, 2017.