RED BANK, N.J., Feb. 22, 2022 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company
dedicated to intercepting and preventing immune-mediated diseases,
today announced it has resubmitted the Biologics License
Application (BLA) for teplizumab for the delay of clinical type 1
diabetes (T1D) in at-risk individuals.
The purpose of the resubmission is to address the FDA's
pharmacokinetic (PK) comparability considerations contained in the
complete response letter (CRL) issued last July, as well as the
CRL's Chemical, Manufacturing, and Controls (CMC) and product
quality considerations. The CRL did not cite any clinical
deficiencies related to the efficacy and safety data packages
submitted to the original BLA. The resubmission comes after last
month's Type B meeting at which the FDA proposed, and the Company
agreed, to use PK modeling to adjust the 14-day dosing regimen for
the planned commercial product to match the exposure of clinical
material used in prior clinical trials by ensuring that the 90%
confidence intervals for relevant PK parameters fall within the
target 80-125% range.
Under applicable FDA guidelines, the FDA has 30 days to review
the resubmission, determine whether it is complete and acceptable
for review, and provide a review goal date.
"We are extremely pleased to have resubmitted the BLA based upon
the potential path forward recommended by the FDA at our Type B
meeting last month. We look forward to the FDA's review and
determination on whether the BLA resubmission sufficiently
addresses the Agency's PK comparability and other CRL
considerations to advance teplizumab towards its first potential
approval as a disease modifying therapeutic option for the T1D
patient community," said Ashleigh
Palmer, Co-Founder and CEO of Provention Bio. "We continue
to proceed with a sense of urgency, recognizing that significant
unmet need exists for patients and their caregivers, and with
gratitude for all of the guidance, collaboration and support
received as we continue to advance this Breakthrough Therapy
Designated product as expeditiously as possible."
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's pipeline includes clinical-stage product candidates
that have demonstrated in pre-clinical or clinical studies
proof-of-mechanism and/or proof-of-concept in autoimmune diseases,
including type 1 diabetes, 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, the Company's potential ability
to successfully address the FDA's PK comparability and other
considerations in the BLA resubmission, FDA's review and potential
approval of teplizumab and potential regulatory and
commercialization timeline. These statements may be identified by
the use of forward-looking words such as "will," "believe,"
"potential" 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 the FDA
disagreeing with the Company's interpretation of data, analysis or
information in the BLA resubmission; delays in or failure to obtain
the FDA approvals for teplizumab or other Company product
candidates and the potential for noncompliance with the FDA
regulations; any inability to successfully work with the FDA to
find a satisfactory solution to address its concerns 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, in the BLA resubmission or otherwise,
satisfactorily address matters cited in the CRL including relating
to PK comparability, product quality, the safety update required by
FDA or any other FDA requirements for 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 September 30, 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
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SOURCE Provention Bio, Inc.