EU Panel Backs Angiotensin II (Giapreza ) for Septic Shock
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended angiotensin II acetate injection (Giapreza, La Jolla Pharmaceutical Co) for 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.
Giapreza mimics the body’s endogenous angiotensin II regulatory peptide that is central to the renin–angiotensin–aldosterone system to increase blood pressure.
Giapreza will be available as a 2.5 mg/mL concentrate for solution for infusion.
Giapreza should be prescribed by physicians experienced in the treatment of shock and used in an acute and hospital setting, the EMA said in a news release. The most common side effects are thromboembolic events, transient hypertension, tachycardia, and peripheral ischemia.
“The CHMP’s positive opinion is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) phase 3 study, which established the safety and efficacy of Giapreza in adults with septic or other distributive shock,” the manufacturer said in a news release.
Detailed recommendations for use of this product will be published in the European public assessment report after the European Commission grants full marketing authorization.
The US Food and Drug Administration (FDA) approved Giapreza to increase blood pressure in adults with septic shock or other distributive shock in 2017.
Prescribing information for Giapreza is available at www.giapreza.com.
Cite this: EU Panel Backs Angiotensin II (Giapreza ) for Septic Shock – Medscape – Jun 28, 2019.