The resubmitted Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals has been accepted for review by the Food and Drug Administration (FDA). The Agency is targeting August 17, 2022 as the date for its decision on the application.
Teplizumab is an investigational anti-CD3 monoclonal antibody that has been shown to preserve beta cell function, reducing the need for exogenous insulin. The BLA includes data from a phase 2 trial (ClinicalTrials.gov Identifier: NCT01030861) that showed treatment with teplizumab significantly delayed progression to clinical T1D by a median of approximately 3 years compared with placebo.
Following the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee vote on teplizumab, the Agency issued a Complete Response Letter (CRL) stating the application could not be approved in its current form due to pharmacokinetic issues. Provention Bio subsequently resubmitted the application addressing the issues cited in the CRL.
“We are delighted to have received the Agency’s acceptance of our BLA resubmission as a complete response to the July 2021 CRL and are excited to have taken yet another significant step towards the potential approval of teplizumab for at-risk T1D individuals as the first ever disease-modifying therapy to delay the onset of this debilitating and life-threatening disease,” said Ashleigh Palmer, Co-Founder and CEO of Provention Bio.
Provention Bio announces FDA acceptance of the Biologics License Application (BLA) resubmission for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. News release. Provention Bio. March 21, 2022. https://www.prnewswire.com/news-releases/provention-bio-announces-fda-acceptance-of-the-biologics-license-application-bla–resubmission-for-teplizumab-for-the-delay-of-clinical-type-1-diabetes-in-at-risk-individuals-301506191.html