Pharmaceutical

La Jolla Pharmaceutical (Nasdaq:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today 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 …

La Jolla Pharmaceutical (Nasdaq:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today 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.

As quoted in the press release:

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 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.

“The submission and validation of the GIAPREZA MAA builds upon the momentum from our recent FDA approval and U.S. launch of GIAPREZA,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We are committed to advancing GIAPREZA globally and fulfilling our mission of providing potentially life-saving therapies to patients in need. We look forward to our discussions with the EMA about GIAPREZA as a new treatment option for patients with septic or other distributive shock.”

Click here to read the full press release.

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