La Jolla Pharma up on new EU approval for hypotension drug Giapreza

Shares of La Jolla Pharmaceutical (Nasdaq: LJPC) rose 5% pre-market yesterday after the company announced that the European Commission 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 Dr George Tidmarsh, president and chief executive of La Jolla.

The EC’s approval is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase III 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.