La Jolla Pharmaceutical Company Receives Positive CHMP Opinion for GIAPREZA™ (angiotensin II) for the Treatment of Refractory Hypotension in Adults with Septic or Other Distributive Shock
“With the CHMP’s adoption of a positive opinion for the Marketing Authorisation Application for GIAPREZA, we are one step closer to bringing this new treatment option to the many critically ill patients suffering from septic or other distributive shock in Europe,” said
The CHMP’s positive opinion 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 CHMP’s positive opinion will now be sent to the
For the CHMP summary of opinion, please visit the following link.
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 regulatory approval of GIAPREZA (angiotensin II) in
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Source: La Jolla Pharmaceutical Company