La Jolla Pharmaceutical Company Announces U.S. FDA Acceptance of New Drug Application for LJPC-501
August 28 2017 - 9:00AM
Business Wire
– Priority Review Granted –
La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or
La Jolla) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the Company’s New
Drug Application (NDA) for the investigational drug LJPC-501
(angiotensin II) for the treatment of hypotension in adults with
distributive or vasodilatory shock who remain hypotensive despite
fluid and vasopressor therapy. The review classification for the
application is Priority, and the user fee goal date under the
Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its
letter to the Company, the FDA stated that it does not currently
plan to hold an advisory committee meeting to discuss this
application.
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of synthetic
human angiotensin II. Angiotensin II is a major bioactive component
of the renin-angiotensin-aldosterone system (RAAS). RAAS is one of
three central regulators of blood pressure. LJPC-501 is being
developed for the treatment of patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy (catecholamines and/or vasopressin).
The New Drug Application for LJPC-501 is based on data from the
ATHOS-3 (Angiotensin II for the Treatment of High Output Shock)
multicenter, randomized, double-blind, placebo-controlled, Phase 3
clinical study of LJPC-501 in patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy. The study was conducted under a Special
Protocol Assessment (SPA) agreed to with the FDA in 2015. A total
of 344 patients were randomized across nine countries, 321 of whom
received study treatment and were included in the primary analysis.
In May 2017, the results of the ATHOS-3 study were published
by The New England Journal of Medicine in an article
entitled “Angiotensin II for the Treatment of Vasodilatory
Shock.”
About Patients with Distributive or Vasodilatory Shock
Failing Standard Therapy
Distributive or vasodilatory shock (dangerously low blood
pressure with adequate cardiac function) can become
life-threatening when a patient is unable to achieve or maintain
target mean arterial pressure (MAP) despite treatment with the
currently available standard of care (fluids and vasopressors).
This life-threatening syndrome has been described as clinically
refractory hypotension, catecholamine-resistant hypotension,
high-dose vasopressor-dependent shock, catecholamine or vasopressor
refractory shock, or catecholamine-resistant vasodilatory shock.
There are approximately 500,000 distributive or vasodilatory shock
patients in the United States per year with an estimated 200,000
patients failing standard therapy. Approximately 50% of these
patients die within 30 days.
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. The Company has
several product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of synthetic human angiotensin II for the
treatment of hypotension in adult patients with distributive or
vasodilatory shock who remain hypotensive despite fluid and
vasopressor therapy. LJPC-401 is La Jolla’s proprietary formulation
of synthetic human hepcidin for the potential treatment of
conditions characterized by iron overload, such as hereditary
hemochromatosis, beta thalassemia, sickle cell disease and
myelodysplastic syndrome. LJPC-30S is La Jolla’s next-generation
gentamicin derivative program that is focused on the potential
treatment of serious bacterial infections as well as rare genetic
disorders, such as cystic fibrosis and Duchenne muscular dystrophy.
For more information on La Jolla, please visit www.ljpc.com.
Forward Looking Statement Safe Harbor
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 future events or the Company’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. The Company 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
the Company’s filings with the U.S. Securities and Exchange
Commission (SEC), all of which are available free of charge on the
SEC’s web site www.sec.gov. These risks include, but are not
limited to, risks relating to: the timing and prospects for
approval of LJPC-501 by the FDA and other regulatory authorities;
risks relating to the scope of product labels (if approved);
potential market sizes; the anticipated timing for regulatory
actions; the impact of pharmaceutical industry regulation and
health care legislation in the United States; and the success
of future development activities. The Company expressly disclaims
any intent to update any forward-looking statements to reflect the
outcome of subsequent events.
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version on businesswire.com: http://www.businesswire.com/news/home/20170828005271/en/
Company ContactsLa Jolla Pharmaceutical CompanySandra
VedrickAssociate Director, Investor Relations & Human
ResourcesPhone: 858-256-7910Email: svedrick@ljpc.comandDennis M.
MulroyChief Financial OfficerPhone: 858-433-6839Email:
dmulroy@ljpc.comorMedia ContactLifeSci Public RelationsMatt
Middleman, M.D.Phone: 646-627-8384Email:
matt.middleman@lifescipublicrelations.com
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