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Provention Maps Possible Regulatory Path For Troubled Teplizumab

Biotech Aims To Get Type A Meeting With FDA In Q4

 
• By Sten Stovall

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.  

Provention Must Address FDA Concerns Cited In Complete Response Letter • Source: Alamy

Provention Bio, Inc. is making some headway in its efforts to unblock the regulatory passage of its potential immunotherapy, teplizumab, following receipt in July of a complete response letter, and plans to request a fourth quarter 2021 Type A meeting with the US Food and Drug Administration to discuss the way forward for the anti-CD3 monoclonal antibody.

The biotech is busy collecting fresh data after receiving the complete response letter regarding its filing for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals. (Also see "Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab" - Pink Sheet, 17 July, 2021

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