Provention Bio To Resubmit BLA For Type 1 Diabetes Therapy In Q1

(RTTNews) - Provention Bio Inc. (PRVB) is all set to resubmit its Biologics License Application seeking approval of Teplizumab for the delay of clinical type 1 diabetes in at-risk individuals this quarter.

The FDA had issued a Complete Response Letter for Teplizumab last July, citing product quality issues and pharmacokinetic concerns.

The company held a Type A meeting with the FDA last November and discussed several concerns related to product quality of Teplizumab that were raised in the Complete Response Letter.

During a recent Type B pre-BLA resubmission meeting with the regulatory agency, the company discussed the FDA feedback and obtained an agreement on its proposed clinical pharmacology data package for Teplizumab.

Commenting on the development, Ashleigh Palmer, Co-Founder and CEO of the company said, "We are very pleased and excited to be working towards resubmitting the teplizumab BLA, taking the FDA's feedback into account, which gets us another step closer to our goal of delivering teplizumab to individuals and their families who are at risk of developing end-stage, insulin-dependent type 1 diabetes."

Following the resubmission of the Biologics License Application, the FDA will have 30 days to review it and determine whether the application is complete and acceptable for review, after which the decision date on Teplizumab will be announced.

Since Teplizumab carries the tags of Breakthrough Therapy Designation and Priority Review designation, the FDA will announce its decision within 6 months of the BLA resubmission.

If approved, Teplizumab would be the first drug to delay the diagnosis of type 1 diabetes in people who are at high risk.

PRVB closed Thursday's trading at $3.40, down 6.59%. In after-hours, the stock was up over 20% at $4.15.