1. Scrip
  2. >>Business

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....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

All Over For iTeos But Applause For Plan To Return Cash Fast

 
• By Kevin Grogan

The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

More from Scrip

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.