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

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

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.

“We want to first and foremost thank everyone throughout the T1D community, the patients, the caregivers and the clinicians for their support today,” said Ashleigh Palmer, co-founder and CEO, Provention Bio. “We especially want to thank T1D clinicians, patients and families for having the courage and conviction to so articulately describe during today’s open public hearing, as well as in the over 180 letters submitted to the EMDAC docket, what it means to live with T1D and how meaningful a delay in onset of two or more years would be. We also want to thank TrialNet, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the investigators and clinical teams, and all the patients and their families who participated in the TN-10 study and contributed to teplizumab-related foundational scientific and clinical research over the past two decades. Finally we would like to thank the EMDAC for their thorough discussion and deliberations resulting in today’s favorable vote. We know the T1D community and at-risk patients and their families in particular are waiting urgently for access to clinical advancements to address their significant medical needs. We remain committed to working closely with the FDA to hopefully secure approval of teplizumab and potentially bring the first disease-modifying therapy in T1D to at-risk patients as soon as possible.”

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