Pharma Focus Asia

La Jolla Pharmaceutical Company Receives European Commission Approval for GIAPREZA™ (angiotensin II)

Friday, August 30, 2019

La Jolla Pharmaceutical Company, 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 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.

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