ChemoCentryx Announces FDA Acceptance of the Avacopan New Drug Application (NDA) for the Treatment of ANCA-Associated Vasculi...
September 17 2020 - 8:30AM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that the U.S.
Food and Drug Administration (FDA) has accepted the Company’s New
Drug Application (NDA) for avacopan, an orally-administered
selective complement 5a receptor inhibitor, for the treatment of
ANCA-Associated Vasculitis and has set July 7, 2021 as the
Prescription Drug User Fee Act (PDUFA) goal date for the avacopan
NDA. Avacopan is a first-in-class, orally administered therapy that
employs a novel, highly targeted mode of action in the treatment of
ANCA-associated vasculitis.
In its NDA acceptance letter, the FDA also indicated that it
may, but has not yet determined whether to hold an advisory
committee meeting to discuss the application per guidelines for new
molecular entities.
The NDA included data from the global, Phase III ADVOCATE trial,
which demonstrated statistical superiority in sustaining remission
at 52 weeks in the avacopan group compared to the prednisone group.
In the trial, the avacopan group also showed significantly lower
glucocorticoid toxicity, greater improvement in kidney function and
greater improvement in health-related quality of life measures
compared to the prednisone group. Finally, avacopan demonstrated
favorable safety results, with fewer patients having serious
adverse events in the avacopan group than in the prednisone
group.
About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global, randomized,
double-blind, active-controlled, double-dummy Phase III trial of
331 patients with ANCA-associated vasculitis in 20 countries.
Eligible study subjects were randomized to receive avacopan plus
either rituximab or cyclophosphamide (followed by
azathioprine/mycophenolate) or prednisone plus either rituximab or
cyclophosphamide (followed by azathioprine/mycophenolate).
ANCA-associated vasculitis is a systemic disease in which
over-activation of the complement pathway further activates
neutrophils, leading to inflammation and destruction of small blood
vessels. This results in organ damage and failure, with the kidney
as the major target, and is fatal if not treated. Currently,
treatment for ANCA-associated vasculitis consists of courses of
non-specific immuno-suppressants (cyclophosphamide or rituximab),
combined with the administration of daily glucocorticoids
(steroids) for prolonged periods of time, which can be associated
with significant clinical risk including death from infection.
About Avacopan Avacopan is a first-in-class,
orally-administered small molecule that employs a novel, highly
targeted mode of action in the treatment of ANCA-associated
vasculitis and other complement-driven autoimmune and inflammatory
diseases. By precisely blocking the receptor (the C5aR) for
the pro-inflammatory complement system fragment known as C5a on
destructive inflammatory cells such as blood neutrophils, avacopan
arrests the ability of those cells to do damage in response to C5a
activation, which is known to be the driver of ANCA-associated
vasculitis. Current therapies for ANCA-associated vasculitis
and other related illnesses typically include broad
immunosuppression with daily doses of glucocorticoids (steroids)
such as prednisone or methylprednisone, which can cause significant
illness and even death. Avacopan therapy was designed to prevent
these outcomes. Moreover, avacopan’s selective inhibition of only
the C5aR leaves the beneficial C5a pathway through the C5L2
receptor functioning normally.
ChemoCentryx is also developing avacopan for the treatment
of patients with C3 glomerulopathy (C3G) and hidradenitis
suppurativa (HS). The U.S. Food and Drug
Administration has granted avacopan orphan drug designation
for ANCA-associated vasculitis and C3G. The European
Commission has granted orphan medicinal product designation
for avacopan for the treatment of two forms of ANCA-associated
vasculitis: microscopic polyangiitis and granulomatosis with
polyangiitis (formerly known as Wegener's granulomatosis), as well
as for C3G.
ChemoCentryx is responsible for the discovery and development of
avacopan and owns and retains the commercial rights to the drug in
the United States. ChemoCentryx's Kidney Health
Alliance with Vifor Pharma provides Vifor Pharma with
exclusive rights to commercialize avacopan in markets outside of
the U.S.
About ChemoCentryx ChemoCentryx is a
biopharmaceutical company developing new medications targeted at
inflammatory and autoimmune diseases and
cancer. ChemoCentryx targets the chemokine and
chemoattractant systems to discover, develop and commercialize
orally-administered therapies. ChemoCentryx’s lead drug candidate,
avacopan (CCX168), successfully completed a pivotal Phase III trial
in ANCA-associated vasculitis.
ChemoCentryx also has early stage drug candidates that
target chemoattractant receptors in other inflammatory and
autoimmune diseases and in cancer.
Forward-Looking StatementsChemoCentryx cautions
that statements included in this press release that are not a
description of historical facts are forward-looking statements.
Words such as "may," "could," "will," "would," "should," "expect,"
"plan," "anticipate," "believe," "estimate," "intend," "predict,"
"seek," "contemplate," "potential," "continue" or "project" or the
negative of these terms or other comparable terminology are
intended to identify forward-looking statements. These statements
include the Company's statements regarding the timing of
anticipated PDUFA date, or whether the FDA will hold an advisory
committee meeting for the avacopan NDA for the treatment of
ANCA-associated vasculitis, the achievement of anticipated goals
and milestones, whether avacopan will be approved by the FDA for
the treatment of ANCA-associated vasculitis, whether avacopan will
be an effective treatment in other indications such as C3G or HS,
and whether the Company's drug candidates will be shown to be
effective in ongoing or future clinical trials. The inclusion of
forward-looking statements should not be regarded as a
representation by ChemoCentryx that any of its plans will be
achieved. Actual results may differ from those set forth in this
release due to the risks and uncertainties inherent in the
ChemoCentryx business and other risks described in the Company's
filings with the Securities and Exchange Commission ("SEC").
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and ChemoCentryx undertakes no obligation to revise or update this
news release to reflect events or circumstances after the date
hereof. Further information regarding these and other risks is
included under the heading "Risk Factors" in ChemoCentryx's
periodic reports filed with the SEC, including ChemoCentryx's
Annual Report on Form 10-K filed with the SEC on March 10, 2020 and
its other reports which are available from the SEC's website
(www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com)
under the heading "Investors." All forward-looking statements are
qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
Contacts:
Susan M. KanayaExecutive Vice President,Chief Financial and
Administrative Officerinvestor@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.com
Investors:Burns McClellan, Inc. Steve
Klass212.213.0006sklass@burnsmc.com
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