The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes

May 28, 2021 Auto Bot diabetes, FDA, Provention Bio, regulatory, Teplizumab 0

Shots:

  • EMDAC has voted 10-7, confirming that the benefits of teplizumab outweigh the risks supporting the approval to delay T1D Mellitus
  • The recommendation is based on a pivotal TN-10 study in which a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least 2yrs. in pre symptomatic patients with stage 2 T1D compared to PBO
  • The US FDA has granted BTD and PR to teplizumab’s BLA. The anticipated PDUFA date is July 2, 2021

Click here to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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