Lilly and Regeneron's EUA for their COVID-19 MAb therapies short of clinically relevant data, say analysts

12 October 2020

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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.”

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