Giapreza filed with EMA for septic shock with hypotension.- La Jolla Pharmaceutical.
La Jolla Pharmaceutical announced that the Marketing Authorisation Application (MAA) for Giapreza (angiotensin II) Injection for Intravenous Infusion was validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission is complete and starts the EMA�s centralized review process. La Jolla submitted the Giapreza MAA for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The MAA is based on data from the ATHOS-3 Phase III study, which establishes the safety and efficacy of Giapreza in the proposed indication. If approved, Giapreza could be available for marketing in the European Union in the second half of 2019.
Comment: In December 2017, Giapreza (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. Giapreza mimics the body�s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure.
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