La Jolla Pharmaceutical Company to Provide GIAPREZA™ (Angiotensin II) for Named Patient Emergency Use in Patients with Sept...
April 02 2020 - 8:30AM
La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated
to the development and commercialization of innovative therapies
that improve outcomes in patients suffering from life-threatening
diseases, today announced that it is providing GIAPREZA™
(angiotensin II) for named patient emergency use in patients with
septic shock due to COVID-19 at Guy’s and St Thomas’ NHS Foundation
Trust in London, United Kingdom. GIAPREZA is being made available
for named patient emergency use based on a request from Marlies
Ostermann, M.D., Consultant in Nephrology and Critical Care at
Guy’s and St. Thomas’ NHS Foundation Trust, London, England.
According to English law, authorized medicines can be made
available prior to commercial availability in order to fulfill
special patient needs. GIAPREZA has been recently approved by the
European Commission but is not yet commercially available in
Europe.
In a report on 44,672 confirmed cases of COVID-19 (Wu et al,
JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of
patients required hospitalization, and, among those, one-third
became critically ill. Patients who became critically ill developed
respiratory failure, septic shock and/or multiple organ failure.
Approximately one-half of the critically ill patients died.
“La Jolla is committed to helping patients suffering from
life-threatening diseases, and we hope that GIAPREZA will
positively impact these patients,” said Lakhmir Chawla, M.D., Chief
Medical Officer, La Jolla Pharmaceutical Company.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was approved by the
U.S. Food and Drug Administration (FDA) as a vasoconstrictor
indicated to increase blood pressure in adults with septic or other
distributive shock. In August 2019, GIAPREZA was approved by the
European Commission (EC) for the treatment of refractory
hypotension in adults with septic or other distributive shock who
remain hypotensive despite adequate volume restitution and
application of catecholamines and other available vasopressor
therapies. GIAPREZA mimics the body’s endogenous angiotensin II
peptide, which is central to the renin-angiotensin-aldosterone
system, which in turn regulates blood pressure. Prescribing
information for GIAPREZA is available at www.giapreza.com. The
European Summary of Product Characteristics is available on the EMA
website:
https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza.
GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company
on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
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 that were reported in greater
than 10% of GIAPREZA-treated patients were thromboembolic
events.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase
response to GIAPREZA. Angiotensin II receptor blockers (ARBs) 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 for the United States and the Summary of Product
Characteristics for the European Union.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development
and commercialization of innovative therapies that improve outcomes
in patients suffering from life-threatening diseases. In December
2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and
Drug Administration (FDA) as a vasoconstrictor indicated to
increase blood pressure in adults with septic or other distributive
shock. In August 2019, GIAPREZA was approved by the European
Commission (EC) for the treatment of refractory hypotension in
adults with septic or other distributive shock who remain
hypotensive despite adequate volume restitution and application of
catecholamines and other available vasopressor therapies. LJPC-0118
(artesunate) is La Jolla’s investigational product for the
treatment of severe malaria. For more information, please visit
www.ljpc.com.
Forward-looking Statements
This press release contains “forward-looking statements” as
defined by the Private Securities Litigation Reform Act of 1995. We
caution investors that forward-looking statements are based on
management’s expectations and assumptions as of the date of this
press release and involve substantial risks and uncertainties that
could cause the actual outcomes to differ materially from what we
currently expect. These risks and uncertainties include, but are
not limited to, those associated with: GIAPREZA™ (angiotensin II)
sales; regulatory actions relating to La Jolla’s products by the
U.S. Food and Drug Administration (FDA), European Commission and/or
other regulatory authorities; cash used in operating activities and
our capital requirements; and other risks and uncertainties
identified in our filings with the U.S. Securities and Exchange
Commission. Forward-looking statements in this press release apply
only as of the date made, and we undertake no obligation to update
or revise any forward-looking statements to reflect subsequent
events or circumstances.
Company Contacts
Sandra VedrickLa Jolla Pharmaceutical CompanyPhone: (858)
207-4264 Ext: 1135Email: svedrick@ljpc.com
and
Dennis MulroyChief Financial OfficerLa Jolla Pharmaceutical
CompanyPhone: (858) 207-4264 Ext: 1040Email: dmulroy@ljpc.com
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