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

COVID Antibody Products May Get To Use Viral Load As Surrogate For Mutant-Targeted Versions

Executive Summary

Former US FDA commissioners say that data for Lilly and Regeneron’s authorized mABs suggesting that reduced viral load correlates with clinical benefit potentially paves the way for emergency authorization or accelerated approval of mABs specifically designed to target emerging variants of the SARS-CoV-2 virus.

You may also be interested in...



Keeping Track: New Uses For Opdivo, Trodelvy; Nextstellis Introduces A Novel Estrogen

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

Lilly And GSK/Vir Antibody Combo Reduces COVID-19 Viral Load

Top-line Phase II data show that a combo of bamlanivimab and VIR-7831, neutralizing antibodies to the SARS-CoV-2 spike protein, yielded a relative 70% reduction in viral load.

US FDA Authorizes Lilly’s COVID-19 mAB Combo For Lower Doses Than Tested In Phase III

The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143804

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