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FDA rejects Provention Bio s type 1 diabetes prevention drug

FDA rejects Provention Bio s type 1 diabetes prevention drug
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Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-risk Individuals

Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-risk Individuals
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FDA Advisory Committee Votes in Favor of the Benefits of Teplizumab Outweighing the Risks in Support of Approval to Delay Clinical Type 1 Diabetes (T1D)

/PRNewswire/ Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today.

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FDA Advisory Votes on Benefits of the Teplizumab to Outweigh Risks in Support of Approval to Delay Clinical Type 1 Diabetes | #site_titleFDA Advisory Votes on Benefits of the Teplizumab to Outweigh Risks in Support of Approval to Delay Clinical Type 1 Diabetes

Posted on Provention Bio, Inc. (NASDAQ: PRVB)reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration voted 10 yes and 7 no on the question, “Does the information provided in the background documents and presentations by the Applicant and FDA show that the benefits of teplizumab outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus?”. The recommendation on safety and efficacy data from the pivotal TN-10 Study in the single 14 day course of teplizumab delayed insulin dependent, disease by a median of atleast two years in presymptomatic patients with Stage 2 type 1 (T1D) compared to placebo. This acknowledges the unmet medical need facing early stage T1D patients.

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FDA panel backs Provention Bio s type 1 prevention drug teplizumab

FDA panel backs Provention Bio’s type 1 prevention drug teplizumab Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug A US Food and Drug Administration (FDA) panel has voted in favour of Provention Bio’s type 1 diabetes prevention drug teplizumab, setting it up for a potential approval in July. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 in favour of the benefits of teplizumab outweighing its risks to support approval of the drug to delay type 1 diabetes. The EMDAC based its recommendation on data from the phase 2 TN-10 study, which randomly assigned 76 participants aged eight to 45 years old to receive a 14-day treatment course of teplizumab or placebo.

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