25 June 2018 -  La Jolla Pharmaceutical Company today announced that the marketing authorisation application for Giapreza (angiotensin II) injection for intravenous infusion was validated by the EMA. 

Validation of the application confirms that the submission is complete and starts the EMA’s centralised review process. La Jolla submitted the Giapreza application 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 3 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.

Read La Jolla Pharmaceutical press release