RED BANK, N.J., Jan. 4, 2021 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced that the Biologics License Application (BLA) for
teplizumab for the delay or prevention of clinical type 1 diabetes
(T1D) in at-risk individuals has been filed by the U.S. Food and
Drug Administration (FDA). The FDA also granted Provention's
request for Priority Review and assigned a user fee goal date of
July 2, 2021, under the Prescription
Drug User-Fee Act (PDUFA).
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"The FDA's acceptance of our BLA represents a significant
achievement for Provention Bio in our mission to deliver the first
potential disease-modifying T1D therapy and drive a paradigm shift
in how individuals at risk of developing the disease are treated,"
stated Ashleigh Palmer, CEO and
Co-Founder, Provention Bio. "We intend to work closely with the FDA
to support their review while also preparing for a potential
product launch in the third quarter of 2021."
In its acceptance letter, the FDA stated that it is currently
planning to hold an advisory committee meeting, tentatively
scheduled for May 27, 2021.
Priority Review is afforded to drugs that, if approved, would
represent a significant improvement in the safety or effectiveness
of the treatment, diagnosis, or prevention of a serious condition.
Under the PDUFA, a Priority Review targets a review time of six
months compared to a standard review time of ten months. The
FDA previously granted teplizumab Breakthrough Therapy
Designation.
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 or prevention of clinical 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, a measure of endogenous insulin production, and
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 Bio has submitted a Biologic License Application (BLA)
to the FDA for teplizumab for the delay or prevention of clinical
type 1 diabetes in at-risk individuals. 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 disease. The Company has submitted
a Biologics License Application (BLA) to the FDA for its lead
investigational drug candidate, teplizumab, for the delay or
prevention of clinical type 1 diabetes in at-risk individuals. 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 FD. 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 and commercial launch of teplizumab, including timelines
relating to the same and the potential therapeutic effects of
teplizumab and the Company's product candidates. These statements
may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimate," "expect," and
"intend," 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; the potential
impacts of COVID-19 on our business and financial results; changes
in law, regulations, or interpretations and enforcement of
regulatory guidance; uncertainties of patent protection and
litigation; the Company's dependence upon third parties;
substantial competition; the Company's need for additional
financing and the risks listed under "Risk Factors" in the
Company's annual report on Form 10-K for the year
ended December 31, 2019, quarterly reports on form 10-Q, 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:
Sam
Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.