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A user fee goal date of August 17, 2022 has been assigned to teplizumab.
Today, the US Food and Drug Administration (FDA) accepted the resubmitted Biologics License Application (BLA) from Provention Bio for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
The resubmitted BLA is considered a complete, class 2 response to the July 2021 action letter by the FDA. A user fee goal date of August 17, 2022 has been assigned to the agent.
“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 in a statement.
"Today's announcement is the result of tremendous dedication and hard work by our team, in conjunction with our collaborative and constructive interactions with the FDA which we look forward to continuing through the ongoing review process,” Palmer continued.
Last July, the complete response letter stated that Provention Bio failed to show pharmacokinetic (PK) comparability in the clinical trials.
They cited a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers comparing planned commercial products originating from drug substances manufactured for historic clinical trials failed to show PK comparability.
In May 2021, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 to support the benefit-risks of teplizumab for delaying clinical T1D. Committee members who voted in favor noted the major clinical need, while those opposed had uncertainties about the target population and limited data set.
Previously, teplizumab was granted Breakthrough Therapy Designation by the FDA. If approved, the therapy would become the first disease-modifying therapy for T1D.