La Jolla Receives European Commission Approval for Giapreza

La Jolla announced that the European Commission (EC) 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.

"We are pleased with the European Commission’s approval of GIAPREZA and look 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, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We are appreciative of the patients, families and dedicated critical care teams who made the development of GIAPREZA possible."

The EC’s 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 recognized in Iceland, Norway and Liechtenstein.

In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) 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. 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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