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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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