RED BANK, NJ, April 8, 2021 / PRNewswire / – Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to catching and preventing immune-related diseases, announced today that the company has received a notice of April 2, 2021 The US Food and Drug Administration (FDA) has determined that as part of its ongoing review of the company’s biological license application (BLA) for teplizumab to delay or prevent clinical type 1 diabetes, the FDA has identified deficiencies that result in a Exclude discussion of the labeling and post-marketing requirements / obligations at this time. The FDA stated in correspondence that the notification did not reflect a final decision on the information to be reviewed.
Additionally during an informal discussion about April 2, 2021 in relation to the agenda for the upcoming meeting of the Advisory Committee for May 27, 2021The FDA announced to the company that it has completed its review of the data and analyzes submitted by the company for their single, low-dose pharmacokinetic / pharmacodynamic (PK / PD) bridging study in healthy volunteers. This study assessed the PK / PD comparability of drugs derived from a drug substance manufactured by AGC Biologics that the company intends to use for commercialization, and drugs derived from a historical drug substance manufactured by Eli Lilly that are used for the The TN-10 study submitted used the teplizumab BLA. The FDA stated that, based on the data reviewed so far, the Agency believed that the PK profiles of the two drugs assessed in the PK / PD bridging study were not comparable and that additional data would be needed before the FDA’s deliberations this could be satisfied. Following this, the FDA announced today to the company that it stands ready to discuss these issues concurrently with its ongoing review.
The FDA intends to continue the review of the clinical data submitted to the BLA and conduct the proposed Advisory Committee meeting May 27th2021.
“While we believe that initial FDA feedback is likely to delay the deadlines within which teplizumab has the potential to be FDA approved and made available to at-risk T1D patients, we believe in the comparability of ours manufactured drug partner of AGC Biologics with the product manufactured by Eli Lilly. We look forward to working closely with the agency to meet the additional data requirements so that we can deliver teplizumab to patients as soon as possible, “he said Ashleigh Palmer, CEO and co-founder of Provention Bio. “In addition, we remain excited about the clinical efficacy and safety data presented with the BLA in support of the potential of teplizumab to address the high unmet needs of T1D patients and look forward to meeting the FDA Advisory Committee and on hearing patients, KOLs and other key stakeholders next month. ”
Conference call and webcast information:
Provention Bio will discuss these business updates via a conference call today at 5:00 p.m. ET. To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) ten minutes prior to the start time and ask for a connection to the Provention Bio Call. An audio webcast will also be available on the Events and Webcasts page in the Investors section of the company’s website at www.proventionbio.com. An archived webcast will be available on the company’s website approximately two hours after the conference call.
About teplizumab (PRV-031):
Teplizumab is an anti-CD3-anti-CD3 monoclonal antibody (mAb) with a BLA submitted by the FDA under Priority Review to delay or prevent clinical type 1 diabetes (T1D) in people at risk. More than 800 patients have received teplizumab in multiple clinical trials with more than 1,000 subjects. In previous studies in newly diagnosed patients, teplizumab consistently demonstrated the ability to maintain beta cell function, a measure of endogenous insulin production. The need for exogenous insulin consumption has been reduced accordingly. Teplizumab has been recognized as Breakthrough Therapy by the FDA and PRIME by the European Medicines Administration. The prevention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (phase 3 PROTECT study).
About Provention Bio, Inc .:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of research therapies that can target and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab, its leading investigational drug candidate, to delay or prevent clinical type 1 diabetes in people at risk, has been submitted by the US Food and Drug Administration (FDA). The company’s pipeline includes additional clinical-stage product candidates that have demonstrated the mechanism and / or the concept in other autoimmune diseases, including celiac disease and lupus, in preclinical or clinical studies. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
Internet publication of information:
Provention Bio, Inc. uses its website www.proventionbio.com as a means of disclosing material non-public information and complying with its disclosure requirements under Regulation FD. This information will be posted on the company’s website in the “News” section. Accordingly, investors should monitor and follow this portion of the company’s website in addition to 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 regarding the regulatory review of the BLA filing for teplizumab and the possible approval and commercialization of teplizumab, including deadlines relating to these and the potential therapeutic effects and safety of teplizumab. These statements can be identified by the use of forward-looking words such as “anticipate”, “believe”, “project”, “estimate”, “expect” and “intend”. 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 expressed in such forward-looking statements. These factors include, but are not limited to, risks associated with delay or failure to obtain FDA approvals for teplizumab or any of the Company’s product candidates, and the potential for non-compliance with FDA regulations; the potential impact of COVID-19 on our business and financial results; Changes in law, regulation, or interpretation and enforcement of policies; Uncertainties regarding patent protection and litigation; the company’s dependence on third parties; significant competition; the company’s need for additional funding and the risks listed under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, and any subsequent filings with the Securities and Exchange Commission. As with any drug in development, there are significant risks associated with the development, regulatory approval and commercialization of new products. Provention is under no obligation to update or revise any forward-looking statements as a result of new information, future developments or for any other reason, except as required by law. The information contained herein is only valid as of the date of this Agreement.
Investor contacts:
Robert Doody, VP of Investor Relations
[email protected]
484-639-7235
Sam Martin, Argot Partners
[email protected]
212-600-1902
Media contact:
Lori Rosen, LDR Communications
[email protected]
917-553-6808
SOURCE Provention Bio, Inc.
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