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

  Ref: PRNewswire | Image: PRNewswire