La Jolla Pharmaceutical Company Announces European Medicines Agency Validation of Marketing Authorisation Application for GIAPREZAâ„¢ (angiotensin II)
SAN DIEGO, June 25, 2018 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq:LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the Marketing Authorisation Application (MAA) for GIAPREZA (angiotensin II) Injection for Intravenous Infusion was validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission is complete and starts the EMA’s centralized review process. La Jolla submitted the GIAPREZA MAA for the treatment of hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The MAA is based on data from the ATHOS-3 Phase 3 study, which establishes the safety and efficacy of GIAPREZA in the proposed indication. If approved, GIAPREZA could be available for marketing in the European Union in the second half of 2019.
“The submission and validation of the GIAPREZA MAA builds upon the momentum from our recent FDA approval and U.S. launch of GIAPREZA,†said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We are committed to advancing GIAPREZA globally and fulfilling our mission of providing potentially life-saving therapies to patients in need. We look forward to our discussions with the EMA about GIAPREZA as a new treatment option for patients with septic or other distributive shock.â€
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor 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. GIAPREZA is marketed 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 (ARB) may reduce response to GIAPREZA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please seeFull 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. In the European Union, the annual incidence of sepsis in adults is estimated to be more than 500,000, with more than 170,000 progressing to septic shock.
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: the timing and outcome of the European Medicines Agency’s (EMA) decision with respect to the Marketing Authorisation Application (MAA) for GIAPREZA; the anticipated treatment of clinical data by the EMA, including whether such data will be sufficient for MAA approval of GIAPREZA; the EMA’s decision regarding labeling and other matters that could affect the availability or commercial potential of GIAPREZA; 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 Vedrick
Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: svedrick@ljpc.com
and
Dennis M. Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: dmulroy@ljpc.com
Media Contact
Sylvia Wheeler
Wheelhouse Life Science Advisors
Email: swheeler@wheelhouselsa.comÂ
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