Provention Bio Announces Biologics License Application (BLA) Resubmission For Teplizumab To Address Complete Response Letter (CRL)
Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced it has resubmitted the Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
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The purpose of the resubmission is to address the FDA’s pharmacokinetic (PK) comparability considerations contained in the complete response letter (CRL) issued last July, as well as the CRL’s Chemical, Manufacturing, and Controls (CMC) and product quality considerations. The CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the original BLA. The resubmission comes after last month’s Type B meeting at which the FDA proposed, and 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 80-125% range.
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Under applicable FDA guidelines, the FDA has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date.
“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. We look forward to the FDA’s review and determination on whether the BLA resubmission sufficiently addresses the Agency’s PK comparability and other CRL considerations to advance teplizumab towards its first potential approval as a disease modifying therapeutic option for the T1D patient community,” 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.”
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