Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Provention Bio’s Teplizumab Delays Type 1 Diabetes Onset, US FDA Says

Executive Summary

Advisory committee to consider whether two-year delay is clinically meaningful and substantial evidence standard is satisfied; notably, panel input is not requested on an issue that has tripped up BLA review - bridging data that suggest pharmacokinetic differences between the clinical trial and commercial drug products.

You may also be interested in...



Provention Maps Possible Regulatory Path For Troubled Teplizumab

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Panel Nod For Teplizumab To Delay Type 1 Diabetes Comes On Strength Of Single Study

Advisory committee members say Provention Bio’s meta-analysis of biomarker data from other type 1 diabetes trials cannot serve as confirmatory evidence to satisfy the ‘substantial evidence’ standard, creating a potentially awkward situation for the agency when it comes to making an approval decision.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144378

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel