Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the U.S. Food & Drug Administration for Voc...
March 16 2020 - 6:05AM
Business Wire
- Company remains on track to complete
submission by the end of the second quarter 2020 -
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”), a late-stage clinical biopharmaceutical company
focused on advancing voclosporin in multiple indications, announced
today that the Company has initiated a Rolling Submission of its
New Drug Application (“NDA”) to the U.S. Food and Drug
Administration (“FDA”) for voclosporin, a next-generation
calcineurin inhibitor for the treatment of lupus nephritis (“LN”).
The rolling NDA allows completed portions of an NDA to be submitted
and reviewed by the Agency on an ongoing basis. Aurinia has
submitted the Nonclinical Module and expects to complete the
submission of all Modules by the end of the second quarter of
2020.
“Following a positive pre-NDA meeting with the FDA in February,
we are pleased to initiate our rolling NDA submission to the
Agency, a critical step toward making voclosporin available to
patients as soon as possible. We look forward to working with the
FDA throughout the process,” commented Larry Mandt, Senior Vice
President, Quality and Regulatory Affairs at Aurinia.
Voclosporin was granted Fast Track designation by the FDA in
2016, with a Priority Review to be requested as part of the
complete NDA submission anticipated by the end of Q2 2020.
About Aurinia
Aurinia Pharmaceuticals is a late clinical-stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are impacted
by diseases with a high unmet medical need. The Company is
currently developing an investigational drug for the treatment of
LN, focal segmental glomerulosclerosis (“FSGS”) and dry eye
syndrome (“DES”). The Company’s head office is in Victoria, British
Columbia and focuses its development efforts globally. For further
information, see our website at www.auriniapharma.com.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: completing
the submission of all modules to the FDA by the end of the second
quarter of 2020; receiving a positive review of the NDA; and
receiving approval during early 2021. It is possible that such
results or conclusions may change based on further analyses of
these data. Words such as “anticipate”, “will”, “believe”,
“estimate”, “expect”, “intend”, “target”, “plan”, “goals”,
“objectives”, “may” and other similar words and expressions,
identify forward-looking statements. We have made numerous
assumptions about the forward-looking statements and information
contained herein, including among other things, assumptions about:
Aurinia being able to obtain all necessary regulatory approvals for
commercialization of voclosporin for use in LN on terms that are
acceptable to it and that are commercially viable; and global
conditions may cause delays in regulation approvals, including
those caused by or related to the novel coronavirus. Even though
the management of Aurinia believes that the assumptions made, and
the expectations represented by such statements or information are
reasonable, there can be no assurance that the forward-looking
information will prove to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, the
following: Aurinia may not be able to obtain necessary regulatory
approvals for commercialization of voclosporin in a timely fashion,
or at all (including any delays caused or related to the novel
coronavirus). Although we have attempted to identify factors that
would cause actual actions, events or results to differ materially
from those described in forward-looking statements and information,
there may be other factors that cause actual results, performances,
achievements or events to not be as anticipated, estimated or
intended. Also, many of the factors are beyond our control. There
can be no assurance that forward-looking statements or information
will prove to be accurate, as actual results and future events
could differ materially from those anticipated in such statements.
Accordingly, you should not place undue reliance on forward-looking
statements or information.
Except as required by law, Aurinia will not update
forward-looking information. All forward-looking information
contained in this press release is qualified by this cautionary
statement. Additional information related to Aurinia, including a
detailed list of the risks and uncertainties affecting Aurinia and
its business can be found in Aurinia’s most recent Annual
Information Form available by accessing the Canadian Securities
Administrators’ System for Electronic Document Analysis and
Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities
and Exchange Commission’s Electronic Document Gathering and
Retrieval System (EDGAR) website at www.sec.gov/edgar.
We seek safe harbour.
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version on businesswire.com: https://www.businesswire.com/news/home/20200316005245/en/
Investor & Corporate Contact: Glenn Schulman, PharmD,
MPH Corporate Communications, Aurinia gschulman@auriniapharma.com
Media Contact Krystle Gibbs Ten Bridge Communications
krystle@tenbridgecommunications.com
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