GIAPREZA™ (angiotensin II) Significantly Improved Survival and Reduced Time on Renal Replacement Therapy in Patients with A...
March 06 2018 - 2:40PM
Analyses to Be Presented in Oral and Poster
Sessions at The 23rd International Conference on Advances in
Critical Care Nephrology AKI & CRRT 2018
La Jolla Pharmaceutical Company (Nasdaq:LJPC) today announced the
release of data from analyses of the impact of
GIAPREZA™ (angiotensin II) on outcomes of a subset of patients
with acute kidney injury requiring renal replacement therapy
(AKI-RRT) enrolled in the ATHOS-3 (Angiotensin II for the Treatment
of High Output Shock) study.
The presentation, entitled “Outcomes in Patients with Acute
Kidney Injury Receiving Angiotensin II for Vasodilatory
Shock,” will take place during The 23rd International
Conference on Advances in Critical Care Nephrology - AKI & CRRT
2018, being held March 6-9, 2018 in San Diego, California. The
manuscript, entitled “Outcomes in patients with vasodilatory shock
and renal replacement therapy treated with intravenous angiotensin
II” was published online in Critical Care Medicine.
“Acute kidney injury requiring dialysis associated with
distributive shock, also referred to as vasodilatory shock,
represents a significant medical risk for patients and a
significant financial burden to the health care system,” said James
Tumlin M.D., Professor of Medicine and Director of NephroNet
Clinical Trials Consortium. “These analyses of the effect of
angiotensin II on AKI patients requiring dialysis in the ATHOS-3
study demonstrated angiotensin II is a promising therapy to address
this unmet need.”
The presentations and manuscript detail the outcomes of patients
with acute kidney injury (AKI) and vasodilatory shock enrolled in
the ATHOS-3 study of GIAPREZA. In this post-hoc analysis, the data
from 105 AKI patients (GIAPREZA n=45; placebo n=60) requiring renal
replacement therapy (RRT) at study drug initiation were analyzed.
Survival through day 28 was 53% (95% CI: 38%-67%) for the GIAPREZA
group compared to 30% (95% CI: 19%-41%) for the placebo group (p =
0.012). By day 7, 38% (95% CI: 25%-54%) of patients treated with
GIAPREZA discontinued RRT compared to 15% (95% CI: 8%-27%) of
patients treated with placebo (p = 0.007). Mean arterial pressure
(MAP) response at hour 3 was achieved in 53% (95% CI: 38%-68%) of
patients treated with GIAPREZA compared to 22% (95% CI: 12%-34%) of
patients treated with placebo (p = 0.001).
23rd International Conference on Advances in Critical Care
Nephrology - AKI & CRRT 2018 Presentation
Details |
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Presentation
Title: |
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Outcomes in Patients
with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory
Shock |
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Presenter: |
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James Tumlin, M.D.,
Professor of Medicine and Director of NephroNet Clinical Trials
Consortium |
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Poster
Presentation Date: |
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Tuesday, March 6, 2018
5:30 pm - 7:00 pm and Wednesday, March 7, 2018 6:00 pm - 8:00 pm
Pacific Time |
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Oral
Presentation Date: |
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Friday, March 9, 2018
11:00 am – 12:25 pm Pacific Time |
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Location: |
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Manchester Grand Hyatt,
San Diego, CA |
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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. Prescribing information for GIAPREZA is
available at www.giapreza.com.
IMPORTANT SAFETY INFORMATION
Contraindications
None
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.
Adverse Reactions
The most common adverse reactions reported in greater than 10%
in GIAPREZA treated patients were thromboembolic events.
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 Shock and Septic or Other Distributive
Shock
Over 1 million Americans are affected by shock on an annual
basis, with 1 in 3 patients being treated for shock in the
intensive care unit. Distributive shock is the most common type of
shock in the inpatient setting with approximately 800,000
distributive shock cases in the United States per year. Of these
cases, an estimated 90% are septic shock patients. Approximately
300,000 do not achieve adequate blood pressure response with
standard of care vasopressor therapy (catecholamines and
vasopressin). 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 a mortality rate exceeding most acute
conditions requiring hospitalization.
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: 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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