GIAPREZA™ (angiotensin II) Significantly Improved Survival of Patients with High APACHE II Scores in ATHOS-3 Study
February 25 2018 - 9:00AM
La Jolla Pharmaceutical Company (Nasdaq:LJPC) today announced that
an abstract, entitled “Effect of Disease Severity on Survival in
Patients Receiving Angiotensin II for Vasodilatory Shock,” will be
presented at the Society of Critical Care Medicine’s (SCCM) 47th
Critical Care Congress, being held from February 25 to 28, 2018 in
San Antonio, Texas.
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
Number: |
6 |
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 |
About GIAPREZA
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
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.
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.
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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