Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced today that the U.S. Food and Drug Administration (FDA) posted briefing documents for the May 27, 2021 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the Biologics License Application (BLA) for teplizumab, Provention Bio's investigational drug candidate for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
The Advisory Committee meeting is scheduled for 9:00 a.m. EST on Thursday, May 27. The briefing materials and the meeting can be accessed at: https://investors.proventionbio.com/events. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.
"We would like to recognize the FDA for their ongoing efforts in the review of the BLA for teplizumab and for convening this Advisory Committee meeting of key endocrinology leaders to discuss the potential merits of teplizumab as the first ever disease modifying therapy for T1D," stated Ashleigh Palmer, Provention Bio's CEO. "Additionally, we want to thank all of those throughout the T1D community, who have played a critical role in advancing T1D research and development, through clinical trial participation, advocacy efforts, screening, as well as making their voices heard throughout the process. It is your endless passion and tenacity towards seeking better solutions that has brought us this far, and together we will strive forward working to seek advancements for the lives of patients with T1D."
On January 4, 2021, Provention Bio announced the FDA filing of the BLA and Priority Review for teplizumab for the delay of clinical T1D in at-risk individuals. Teplizumab has been granted Breakthrough Therapy Designation. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the BLA of July 2, 2021.
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