RED BANK, N.J., May 25, 2021 /PRNewswire/ -- Provention Bio,
Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, announced
today that the U.S. Food and Drug Administration (FDA) posted
briefing documents for the May 27,
2021 Endocrinologic and Metabolic Drugs Advisory Committee
(EMDAC) meeting to review the Biologics License Application (BLA)
for teplizumab, Provention Bio's investigational drug candidate for
the delay of clinical type 1 diabetes (T1D) in at-risk
individuals.
The Advisory Committee meeting is scheduled for 9:00 a.m. EST on Thursday, May 27. The
briefing materials and the meeting can be accessed at:
https://investors.proventionbio.com/events. The Company is
not responsible for the content of, nor the statements made in, the
briefing materials that were prepared by the FDA.
"We would like to recognize the FDA for their ongoing efforts in
the review of the BLA for teplizumab and for convening this
Advisory Committee meeting of key endocrinology leaders to discuss
the potential merits of teplizumab as the first ever disease
modifying therapy for T1D," stated Ashleigh
Palmer, Provention Bio's CEO. "Additionally, we want
to thank all of those throughout the T1D community, who have played
a critical role in advancing T1D research and development, through
clinical trial participation, advocacy efforts, screening, as well
as making their voices heard throughout the process. It is
your endless passion and tenacity towards seeking better solutions
that has brought us this far, and together we will strive forward
working to seek advancements for the lives of patients with
T1D."
On January 4, 2021, Provention Bio
announced the FDA filing of the BLA and Priority Review for
teplizumab for the delay of clinical T1D in at-risk
individuals. Teplizumab has been granted Breakthrough Therapy
Designation. Based on the Prescription Drug User Fee Act
(PDUFA), the FDA has set an action date for the BLA of July 2, 2021.
The BLA was filed on the pivotal TN-10 Study data that found a
single 14-day course of teplizumab delayed clinical disease and
insulin-dependence by at least two years in presymptomatic patients
with Stage 2 T1D, compared to placebo. Teplizumab was generally
well tolerated and the safety data from TN-10 are consistent with
previous analyses. The main risks are mechanism-based, transient
and predictable including lymphopenia, transaminase elevations,
rash and cytokine release events; we believe these events are
short-lived and manageable because teplizumab is given as a one
course regimen and not chronically.
About Teplizumab (PRV-031):
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb)
with a filed BLA under Priority Review by the FDA for the delay of
clinical type 1 diabetes (T1D) in at-risk individuals. More
than 800 patients have received teplizumab in multiple clinical
studies involving more than 1,000 subjects. In previous
studies of newly diagnosed patients, teplizumab consistently
demonstrated the ability to preserve beta-cell function as shown by
C-peptide, a measure of endogenous insulin production. It
correspondingly reduced the need for exogenous insulin use.
Teplizumab has been granted Breakthrough Therapy Designation by the
FDA and PRIME designation by the European Medicines Administration.
Provention is currently also evaluating teplizumab in patients with
newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT
study).
About Provention Bio, Inc.:
Provention Bio, Inc.
(Nasdaq: PRVB) is a biopharmaceutical company focused on advancing
the development of investigational therapies that may intercept and
prevent debilitating and life-threatening immune-mediated diseases.
The BLA for teplizumab, its lead investigational drug candidate,
for the delay of clinical T1D in at-risk individuals has been filed
by the FDA. The Company's pipeline includes additional
clinical-stage product candidates that have demonstrated in
pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in other autoimmune diseases, including celiac
disease and lupus. Visit www.ProventionBio.com for more
information and follow us on Twitter: @ProventionBio.
Internet Posting of Information:
Provention Bio, Inc. uses its website, www.proventionbio.com,
as a means of disclosing material nonpublic information and for
complying with its disclosure obligations under Regulation F.D.
Such disclosures will be included on the Company's website in the
"News" section. Accordingly, investors should monitor this portion
of the Company's website, in addition to following its press
releases, SEC filings and public conference calls and
webcasts.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to regulatory
review of the BLA submission for teplizumab and the potential
approval of teplizumab, the upcoming Advisory Committee meeting,
the potential safety and therapeutic effects of our investigational
therapies, including teplizumab, and our plans to seek advancements
for the lives of patients with T1D. These statements may be
identified by the use of forward-looking words such as "believe,"
"likely," and "may," among others. These forward-looking statements
are based on the Company's current expectations and actual results
could differ materially. There are a number of factors that could
cause actual events to differ materially from those indicated by
such forward-looking statements. These factors include, but are not
limited to, risks related to delays in or failure to obtain FDA
approvals for teplizumab or other Company product candidates and
the potential for noncompliance with FDA regulations; any inability
to successfully work with FDA to find a satisfactory solution to
address its concerns in a timely manner or at all, including the
inability to successfully demonstrate to the FDA, the ultimate
decision maker on the matter, adequate PK comparability between the
to-be-marketed teplizumab product and the product used in the TN-10
study; any inability to provide the FDA with PK/PD data from our
on-going Phase 3 PROTECT study or other data sufficient to support
an approval of the BLA for teplizumab; and the risks listed
under "Risk Factors" in the Company's quarterly report on Form 10-Q
for the quarter ended March 31, 2021 and any subsequent
filings with the Securities and Exchange Commission. As with any
pharmaceutical under development, there are significant risks in
the development, regulatory approval and commercialization of new
products. Provention does not undertake an obligation to update or
revise any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by applicable law. The information set forth herein speaks
only as of the date hereof.
Investor Contact:
Robert
Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235
Media Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.