ChemoCentryx Announces Filing of Amendment to NDA Submission and Extension of the PDUFA Review Period for Avacopan in the Tre...
06 July 2021 - 10:30PM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that, following
consultations with the U.S. Food and Drug Administration (FDA), it
filed an amendment to its New Drug Application (NDA) for avacopan
for the treatment of Anti-neutrophil Cytoplasmic Autoantibody
(ANCA)-associated vasculitis, addressing points raised during the
FDA Advisory Committee meeting on May 6, 2021. The FDA has
indicated that the filing constitutes a major amendment to the NDA
and will result in the setting of a new PDUFA goal date of October
7, 2021. The NDA is primarily based on data from the Phase III
ADVOCATE trial of avacopan for the treatment of ANCA-associated
vasculitis. On May 6, the FDA’s Arthritis Advisory Committee voted
9-9 on whether the efficacy data support approval of avacopan, 10-8
that the safety profile of avacopan is adequate to support
approval, and 10-8 that the benefit-risk profile is adequate to
support approval of avacopan at the proposed dose of 30 mg twice
daily.
“We appreciate the opportunity to put additional data and
information before the Agency, information which we believe
addresses many of the issues raised at the Advisory Committee
meeting,” said Thomas J. Schall, Ph.D., President and Chief
Executive Officer of ChemoCentryx. “We look forward to continuing
discussions with the Agency.”
The Marketing Authorization Application (MAA) for avacopan in
the treatment of ANCA-associated vasculitis was validated by the
European Medicines Agency (EMA) in November 2020, and the Japanese
New Drug Application was accepted for review by the Japanese
Pharmaceuticals and Medical Device Agency in February 2021.
About ADVOCATE and ANCA-Associated
VasculitisThe 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 study-supplied oral prednisone plus
either rituximab or cyclophosphamide (followed by
azathioprine/mycophenolate). Subjects in both treatment groups
could also receive non-protocol glucocorticoids if needed.
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 AvacopanAvacopan 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’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 ChemoCentryxChemoCentryx is a
biopharmaceutical company developing new medications for
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
and is in late stage clinical development for the treatment of
severe Hidradenitis Suppurativa and C3 glomerulopathy
(C3G). 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 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, 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 1, 2021 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.Lee
Roth212.213.0006lroth@burnsmc.com
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