As US President Donald Trump puts his weight behind Eli Lilly (NYSE: LLY) and Regeneron Pharmaceuticals’ (Nasdaq: REGN) bid for US Food and Drug Administration Emergency Use Authorization (EUA) for their respective COVID-19 monoclonal antibody (MAb) therapies, pharma writers for the investigative team at GlobalData assess the situation.
“Experts we interviewed emphasized the need for more clinically relevant data for a higher guarantee of a successful EUA,” Manasi Vaidya explained. “Lilly is aiming for its LY-CoV555 monotherapy to win an EUA, while Regeneron’s bid involves its antibody cocktail, REGN-COV2 consisting of REGN10933 and REGN10987, she added.
Fellow writer Reynald Castañeda said: “Despite both MAb therapies showing they can reduce SARS-CoV-2 viral load in non-hospitalized COVID-19 patients, larger prospective datasets on endpoints such as reduced hospitalization and emergency room visits are needed for stronger EUA potential. Available data only offers a slight efficacy signal on these clinically important measures.”
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze