2021-07-07| Trials & Approvals

FDA Rejection of Type 1 Diabetes Drug Impacts Provention Bio’s Stocks

by Daniel Ojeda
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On July 6th, Provention Bio, a biopharmaceutical company specializing in therapeutics for immune-mediated diseases, announced receiving a Complete Response Letter from the FDA for its Type 1 Diabetes drug, teplizumab.

The agency has requested additional information regarding a discrepancy between the planned commercial product and the product used in clinical trials. The setback sent Provention Bio’s stock downward, the value dropping by almost 25% and reaching a new 52-week low.   

  New Jersey-based Provention Bio develops treatments for immune-mediated diseases such as type 1 diabetes, lupus, and celiac disease. Their most advanced investigational candidate is teplizumab (PRV-031), a monoclonal anti-CD3 antibody. It is developed to delay the development of type 1 diabetes (T1D).

 T1D is an autoimmune disease that affects more than 1.6 million people in the US. On average, this disease reduces life expectancy by 10 years, and patients require constant monitoring and insulin treatment. Currently, there are no disease-modifying treatments for T1D.


Favorable Vote from Advisory Committee

Data from the TN-10 study showed that a 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of 2 years when compared to a placebo. Based on these results, the FDA granted Breakthrough Therapy designation, and Provention Bio applied for the Biologics License Application.

On May 27th, the Endocrinologic and Metabolic Drug Advisory Committee voted 10 to 7 in favor of approving teplizumab, saying that its benefits outweigh the risks and the drug delays T1D. However, the FDA is not bound by the advisory committee’s votes. Earlier, the drug regulator had expressed reservations that the TN-10 study had enrolled just a few patients.


CRL from the FDA

In the CRL, the FDA has raised concerns over the discrepancy in pharmacokinetics between the planned commercial product and the product used in clinical trials. Provention Bio now plans to address this issue by providing data from the ongoing Phase 3 PROTECT trial.  

 Additional comments from the FDA included considerations related to product quality and issues with a manufacturing facility used by Provention Bio. The company believes that these concerns have been addressed or can be addressed in a short time.  

 Crucially, the CRL did not mention any issues with safety and efficacy, but they requested a safety update as part of the resubmission.  

 In a press release, Ashleigh Palmer, Co-Founder, and CEO of Provention Bio, emphasized the unmet need of diabetic patients. “We know the T1D community is urgently awaiting therapeutic advancements to address their medical needs and believe our collective passion and commitment will continue to drive us forward to meet this goal. We will continue to work collaboratively with the FDA to hopefully secure approval of teplizumab and bring the first disease-modifying therapy for T1D to at-risk patients as soon as possible.”

Related Article: FDA Approves Jazz Pharma’s Rylaze for Treating Common Leukemia in Children


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