La Jolla Pharmaceutical Company has announced that the European Commission (EC) has approved Giapreza (angiotensin II) for the treatment of certain patients with refractory hypotension in adults with septic or other distributive shock.
The indication is for patients who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase III study, which established the safety and efficacy of the drug in adults with septic or other distributive shock.
In July the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) supported granting a marketing authorisation for the drug for the treatment of refractory hypotension in adults with septic or other distributive shock.
The drug works by mimicking the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure.
The company announced that it is “pleased with the European Commission’s approval of Giapreza”, and that it “looks forward to bringing this new treatment option to the many critically ill European patients suffering from septic or other distributive shock,” said George F. Tidmarsh, president and chief executive officer of La Jolla.
He continued, “We are appreciative of the patients, families and dedicated critical care teams who made the development of Giapreze possible.”
In December 2017, it was approved by the US Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock.