The Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency has recommended the granting of a marketing authorisation for angiotensin II acetate for the treatment of refractory hypotension in adults with septic shock.
The drug is manufactured under the brand name Giapreza by La Jolla Pharmaceuticals.
The drug will be available as a 2.5 mg/ml concentrate for solution for infusion.
Angiotensin II raises blood pressure is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, according to a statement by CHMP.
The most common side effects are thromboembolic events, transient hypertension, tachycardia and peripheral ischaemia.