La Jolla Pharmaceutical Company Announces the Treatment of First Patient in GIAPREZA™ (angiotensin II) Pediatric Study
February 21 2018 - 8:00AM
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.
About GIAPREZA
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
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.
Drug Interactions
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. 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.
Forward-looking Statements
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.
Company Contacts
Sandra VedrickDirector, Investor Relations & Human
ResourcesLa Jolla Pharmaceutical CompanyPhone: (858) 207-4264 Ext:
1135Email: svedrick@ljpc.com
and
Dennis M. MulroyChief Financial OfficerLa Jolla Pharmaceutical
CompanyPhone: (858) 207-4264 Ext: 1040Email: dmulroy@ljpc.com
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