La Jolla Pharmaceutical Company Receives European Commission Approval for GIAPREZA™ (angiotensin II)
“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
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
U.S. IMPORTANT SAFETY INFORMATION
Warnings and Precautions
There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.
The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.
Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARB) may reduce response to GIAPREZA.
You are encouraged to report negative side effects of prescription drugs to the
For additional information, please see Full Prescribing Information for
This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the regulatory approval of GIAPREZA™ (angiotensin II) in
Senior Director, Investor Relations & Human Resources
Phone: (858) 207-4264 Ext: 1135
Chief Financial Officer
Phone: (858) 207-4264 Ext: 1040
Source: La Jolla Pharmaceutical Company