The Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
The new Prescription Drug User Fee Act (PDUFA) target date is November 17, 2022. The FDA extended the action date to allow additional time to review an information request made in June 2022. The Agency considered this information to be a major amendment to 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 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 lifetime of exogenous insulin therapy.”
Provention Bio announces extension of FDA user fee goal date for teplizumab to November 17, 2022. News release. Provention Bio, Inc. Accessed July 1, 2022. https://www.prnewswire.com/news-releases/provention-bio-announces-extension-of-fda-user-fee-goal-date-for-teplizumab-to-november-17-2022-301579153.html