RED
BANK, N.J., June 30,
2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB) (the "Company"), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated diseases, today
announced that the U.S. Food and Drug Administration (FDA) has
extended its review period by three months for the Biologics
License Application (BLA) for teplizumab. The extended User Fee
Goal date is November 17,
2022.
The Company was also informed that if no major deficiencies are
identified during the review period, the FDA plans to communicate
proposed labeling and, if necessary, any post-marketing requirement
or commitment requests by October 17,
2022.
As part of its ongoing review and communications, the FDA
informed the Company yesterday that it considers a timely response
to an information request made earlier this month to be a Major
Amendment to the BLA resubmission, requiring additional time for
the Agency's review.
"We are committed to collaborating closely with the Agency as it
completes its review," said Ashleigh
Palmer, Co-Founder and CEO of Provention Bio. "We want to
thank the FDA for its continued diligence as we continue to work
towards bringing this potential first disease modifying therapy to
patients with type 1 diabetes in the
United States, for whom there is currently no approved
treatment other than a life-time of exogenous insulin therapy."
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
progression to Stage 3 clinical type 1 diabetes 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 the medical
need in T1D at-risk patients, the potential therapeutic effects and
safety of teplizumab in at-risk T1D patients, FDA's review of the
BLA resubmission, including label negotiations, and potential for
approval of teplizumab and potential regulatory and
commercialization timelines. These statements may be identified by
the use of forward-looking words such as "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 FDA
disagreeing with the Company's interpretation of data and analysis
and information in the BLA resubmission; 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 address
its concerns and requests in a timely manner or at all during the
review process for teplizumab, including any inability to provide
the FDA with data, analysis or other information sufficient to
support an approval of the BLA for teplizumab; any inability to
satisfactorily address matters PK comparability, product
quality, safety or any other FDA requirements during the BLA
review process to obtain an approval of teplizumab; 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 quarterly report on Form 10-Q for the quarter ended
March 31, 2022 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:
Kaelan
Hollon, VP of Communications khollon@proventionbio.com
202-421-4921
View original content to download
multimedia:https://www.prnewswire.com/news-releases/provention-bio-announces-extension-of-fda-user-fee-goal-date-for-teplizumab-to-november-17-2022-301579153.html
SOURCE Provention Bio, Inc.