Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

January 4, 2021 Auto Bot BLA, FDA, Prevent, Priority Review, Provention Bio, regulatory, reports, Submission, Teplizumab 0

Shots:

  • The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021
  • The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
  • Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved, teplizumab will be the first disease-modifying therapy for T1D

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

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