News from the FDA/CDC

FDA approves angiotensin II for shock patients


 

Angiotensin II has been approved for use in intravenous infusions to increase blood pressure in adults with septic or other distributive shock, the Food and Drug Administration announced.

Shock-related drops in blood pressure can restrict blood flow to vital organs and 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 written statement.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

The effectiveness of angiotensin II for treating critically low blood pressure was confirmed in a clinical trial of 321 patients who were in shock. A significant number of patients responded to angiotensin II treatment, compared with those given placebo. In combination with conventional treatments, angiotensin II increased blood pressure safely and effectively, according to the FDA statement.

Angiotensin II can cause serious blood clots, and prophylactic treatment for such issues is recommended.

The application for angiontensin II was received under Priority Review. The goal of Priority Review is for the FDA to take action on the application within 6 months if the agency determines that an approved drug would improve the safety and effectiveness of treating a serious medical condition.

Angiotensin II injections will be marketed as Giapreza by La Jolla Pharmaceutical Company.

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