The abstract, which was published in the January Supplement of Critical Care Medicine and online, includes results from a pre-specified analysis from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) Phase 3 study of GIAPREZATM (angiotensin II) in patients with high severity of illness, defined as an APACHE II (Acute Physiology and Chronic Health Evaluation II) score > 30 or baseline MAP < 65 mmHg, despite treatment with high-dose vasopressors. The authors present data showing a lower 28-day mortality rate in patients with baseline APACHE II scores > 30 in the GIAPREZA group versus the placebo group: 28-day mortality was 51.8% (n = 58) for the GIAPREZA group compared to 70.8% (n = 65) for the placebo group (hazard ratio=0.62 [95% CI: 0.39, 0.98; p=0.037]). In patients with a baseline MAP < 65 mmHg, a trend towards improved 28-day mortality was seen in the GIAPREZA group compared to the placebo group: 28-day mortality was 54.2% (n = 52) for the GIAPREZA group compared to 70.4% (n = 50) for the placebo group (hazard ratio=0.66 [95% CI: 0.40, 1.09; p=0.10]).
Society of Critical Care Medicine’s 47th Critical Care Congress Presentation Details
|Star Research Presentation:||Sepsis and Shock|
|Presentation Title:||Effect of Disease Severity on Survival in Patients Receiving Angiotensin II for Vasodilatory Shock|
|Presenter:||Azra Bihorac, M.D., R. Glenn Davis Associate Professor of Medicine, Surgery and Anesthesiology, University of Florida|
|Session Date:||Sunday, February 25, 2018|
|Session Time:||3:45 pm – 5:45 pm Central Time|
|Session Room:||Henry B. Gonzalez Convention Center, Hemisfair Ballroom C1|
In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. In the ATHOS-3 Phase 3 study, the primary endpoint of: (i) a mean arterial pressure (MAP) increase of ≥ 10 mmHg; or (ii) a MAP of ≥ 75 mmHg, was achieved by 70% of patients randomized to GIAPREZA, compared to 23% of patients randomized to placebo (p < 0.0001); both arms were treated with standard-of-care vasopressors. The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg/min via continuous intravenous infusion. Close monitoring during the first 5 minutes of GIAPREZA initiation is recommended. GIAPREZA is available in 1 mL single dose vials, each containing 2.5 mg of angiotensin II (as a sterile liquid). Prescribing information for GIAPREZA is available at www.giapreza.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 Phase 3 study. There was a higher incidence of venous and arterial thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.
Adverse reactions that occurred in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia and peripheral ischemia.
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 FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please see Full Prescribing Information.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. LJPC‑401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. For more information, please visit www.ljpc.com.
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to expectations regarding future events or La Jolla’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. La Jolla cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties and other factors are described in greater detail in La Jolla’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s website www.sec.gov. These risks include, but are not limited to, risks relating to: clinical studies with GIAPREZA may not be successful in evaluating their safety and tolerability or providing evidence of efficacy; unforeseen safety issues from the administration of GIAPREZA in patients; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities; potential market sizes, including for septic or other distributive shock; our ability to successfully commercialize, market and achieve market acceptance of GIAPREZA; and other risks and uncertainties identified in our filings with the SEC. La Jolla expressly disclaims any intent to update any forward‑looking statements to reflect the outcome of subsequent events.
Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Dennis M. Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040