SAN DIEGO, Feb. 21, 2018 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq:LJPC) today announced that the first pediatric patient has been treated in LJ501-CRH02, La Jolla’s open-label study of GIAPREZATM (angiotensin II), injection for intravenous infusion, in pediatric patients (ages 2-17) with shock who remain hypotensive despite receiving fluid and current standard-of-care vasopressor therapy.
LJ501-CRH02 is an open-label study that will enroll approximately 30 patients in 10 pediatric intensive care units across the United States. The primary objective of this study is to evaluate the effect of GIAPREZA on mean arterial pressure (MAP) or total norepinephrine (NE)-equivalent dosing, two hours after the initiation of GIAPREZA.
“We are thrilled to enroll the first pediatric patient in this open-label study of angiotensin II in children with vasodilatory septic or other distributive shock,” said Dwight Bailey, D.O., Specialty Medical Director, Pediatric Critical Care Medicine Division, Atrium Health’s Levine Children’s Hospital in Charlotte, North Carolina. “The critical care team and the patient’s family were grateful to have another option for the treatment of this young patient who we believe was suffering from influenza, which was complicated by a bacterial superinfection and septic shock, especially given the limited therapeutic options for pediatric patients.”
In December 2017, GIAPREZA was approved by the U.S. Food and Drug Administration (FDA) to increase blood pressure in adults with septic or other distributive shock. GIAPREZA (angiotensin II) mimics the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure.
About Patients with Septic or Other Distributive Shock Failing Standard Therapy
Septic or other distributive shock (dangerously low blood pressure with adequate cardiac function) can become life threatening when a patient is unable to achieve target mean arterial pressure (MAP) despite adequate fluid resuscitation and treatment with other available vasopressors (catecholamines and/or vasopressin). Distributive shock is the most common type of shock in the inpatient setting. Shock is prevalent, affecting 1 in 3 intensive care unit patients. There are approximately 800,000 distributive shock cases in the United States each year. Of these cases, an estimated 90% are septic shock patients. Approximately 300,000 of these patients do not achieve adequate blood pressure response with fluids and typical, first-line catecholamine therapy. The inability to achieve or maintain adequate blood pressure results in inadequate blood flow to the body’s organs and tissue and is associated with organ damage and a mortality rate exceeding most acute conditions requiring hospitalization.
In December 2017, GIAPREZATM (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 (angiotensin II) 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 as a carton of 1 mL single dose vials, each containing 2 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 thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the Phase 3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in venous thrombosis. 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 ( Automotive Components Europe ) 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. GIAPREZATM (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 on La Jolla, 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.
Dennis M. Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040