ChemoCentryx Announces Results of FDA Advisory Committee Meeting on Avacopan in ANCA-Associated Vasculitis
May 06 2021 - 11:37PM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced the outcome of
the U.S. Food and Drug Administration (“FDA”) Arthritis Advisory
Committee (“Committee”) on avacopan for the treatment
of Antineutrophil Cytoplasmic Autoantibody (ANCA)-associated
vasculitis (or AAV). In the final part of the public meeting, the
Committee voted on three questions presented by the FDA:
- The Committee vote split 9-9 on the first question, whether the
efficacy data support approval of avacopan for the treatment of
adult patients with AAV (granulomatosis with polyangiitis (GPA) and
microscopic polyangiitis (MPA)).
- On the second question, the Committee voted 10-8 that the
safety profile of avacopan is adequate to support approval of
avacopan for the treatment of adult patients with AAV (GPA and
MPA).
- In the third and final question, the Committee voted 10-8 that
the benefit-risk profile is adequate to support approval of
avacopan at the proposed dose of 30 mg twice daily for the
treatment of adult patients with AAV (GPA and MPA).
“We are grateful to the Committee for their careful
deliberations and look forward to working with the FDA as its
review of our application continues,” said Thomas J. Schall, Ph.D.,
President and Chief Executive Officer of ChemoCentryx. “Discussion
from patients and clinicians during the public forum portion of the
meeting underscored the need for new treatment options.”
“We hope that the FDA will take into account the dire situation
faced by patients living with this debilitating disease,” said
Joyce Kullman, Executive Director, Vasculitis Foundation. ”ANCA
vasculitis flares can lead to kidney failure and death; current
therapy all too often causes serious, even fatal, side effects; and
patients suffer a lower quality of life due to the disease and to
the way it is treated.”
FDA Advisory Committees provide the FDA with independent
opinions and non-binding recommendations from outside medical
experts. While the FDA will consider the opinions expressed and
recommendations made by the Advisory Committee, the FDA will make a
decision regarding whether to approve the NDA for avacopan in
ANCA-associated vasculitis following completion of its review
process.
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 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 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 a New Drug Application is under review by the U.S. Food and
Drug Administration. Avacopan is also 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, whether avacopan will
be an effective treatment in other indications such as C3G or
severe 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 11, 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
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Mar 2024 to Apr 2024
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Apr 2023 to Apr 2024