Posted by Michael Wonder on 02 Sep 2019
La Jolla Pharmaceutical receives European Commission approval for Giapreza (angiotensin II)
29 August 2019 - La Jolla Pharmaceutical Company today announced that the European Commission has approved Giapreza (angiotensin II) 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.
The approval 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 EC’s decision is applicable to the 28 European Union member countries. Approval will also be recognised in Iceland, Norway and Liechtenstein.
