Provention Bio Shares Rise 13% After Plan to Resubmit BLA
January 28 2022 - 10:38AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
January 28, 2022 10:23 ET (15:23 GMT)
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