By Chris Wack
Provention Bio Inc. shares were up 13% to $3.85 Friday after the company said it intends to resubmit the teplizumab biologics license application for the delay of clinical type 1 diabetes in at-risk individuals following its Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.
The company said the purpose of the Type B pre-BLA resubmission meeting was to discuss FDA feedback and obtain agreement on Provention's proposed clinical pharmacology data package.
In preliminary meeting comments, the FDA noted that the data package presented doesn't adequately support pharmacokinetic comparability because predicted primary PK parameters are indicative of a lower exposure.
To address this concern, the FDA proposed, and the company agreed, to use PK modeling to adjust the 14-day dosing regimen for the planned commercial product to match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80% to 125% range. On this basis, the FDA agreed that Provention could proceed to resubmit the BLA.
Under applicable FDA guidelines, the FDA has 30 days to review the BLA resubmission, determine whether it is complete and acceptable for review, and provide the due date for action. Under BTD and priority review designation, the FDA's guidance is to complete its review within six months of the BLA resubmission date.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires