Provention Bio has resubmitted the Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
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 was initially submitted to the Food and Drug Administration (FDA) in November 2020. The application included 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 (PK) issues. Product quality issues and manufacturing deficiencies were also included in the response letter; however, the FDA did not cite any clinical concerns.
After meeting with the FDA, 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 to 125% range” to address the issues cited in the CRL.
“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,” 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.”
Provention Bio announces Biologics License Application (BLA) resubmission for teplizumab to address Complete Response Letter (CRL). News release. Provention Bio, Inc. Accessed February 22, 2022. https://www.prnewswire.com/news-releases/provention-bio-announces-biologics-license-application-bla-resubmission-for-teplizumab-to-address-complete-response-letter-crl-301487021.html.
This article originally appeared on MPR