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# FDA Review Extended on Provention Bio BLA
- URL: https://www.fdaweb.com/fda-review-extended-on-provention-bio-bla/
- Published: 2022-06-30T12:00:00.000Z
- Updated: 2026-09-14T17:50:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152216

FDA has extended by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes in at-risk individuals. The extended user fee review action goal date is 11/7.

The agency recently told the company that its response to an information request made earlier this month is considered a major amendment and thus requires additional time to review. Provention also says it was told that if no major deficiencies are identified during the review period, FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirement or commitment requests by 10/17.