Posted by Michael Wonder on 23 Feb 2022
Provention Bio announces biologics license application resubmission for teplizumab to address complete response letter
22 February 2022 - Provention Bio today announced it has resubmitted the biologics license application for teplizumab for the delay of clinical type 1 diabetes in at risk individuals.
The purpose of the resubmission is to address the FDA's pharmacokinetic comparability considerations contained in the complete response letter issued last July, as well as the letter's Chemical, Manufacturing, and Controls and product quality considerations.
