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ELI LILLY AND COMPANY

(LLY)
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Lilly, Incyte Get Emergency Use Authorization for Covid-19 Treatment as Monotherapy

07/29/2021 | 08:04am EDT

By Chris Wack

Eli Lilly & Co. and Incyte Corp. said the U.S. Food and Drug Administration has broadened the emergency use authorization for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir.

The authorization now provides for the use of baricitinib for treatment of Covid-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

The companies said the FDA based its decision on data from a Phase 3 study, a randomized, placebo-controlled study of hospitalized patients comparing baricitinib 4 mg once daily plus standard of care versus placebo plus standard of care.

While the composite primary endpoint of the study, which was defined as a difference in the estimated proportion of participants progressing to non-invasive ventilation including high flow oxygen or invasive mechanical ventilation or death by day 28, didn't meet statistical significance, baricitinib-treated patients were less likely than those receiving standard of care to progress to ventilation or death.

A pre-specified key secondary endpoint showed baricitinib, in addition to standard of care, meaningfully reduced the risk of death by 39% by day 28. No new safety signals potentially related to the use of baricitinib were identified.

Under the emergency use authorization, inpatient pharmacies in the U.S. may order 1-mg and 2-mg tablets of baricitinib through Lilly's authorized distributors.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

07-29-21 1004ET

Stocks mentioned in the article
ChangeLast1st jan.
ELI LILLY AND COMPANY 1.92% 232.18 Delayed Quote.35.22%
INCYTE CORPORATION 0.68% 70.0854 Delayed Quote.-12.55%
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Financials (USD)
Sales 2021 27 235 M - -
Net income 2021 6 346 M - -
Net Debt 2021 11 480 M - -
P/E ratio 2021 32,8x
Yield 2021 1,43%
Capitalization 207 B 207 B -
EV / Sales 2021 8,02x
EV / Sales 2022 7,77x
Nbr of Employees 35 000
Free-Float 99,8%
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Number of Analysts 19
Last Close Price 228,30 $
Average target price 265,00 $
Spread / Average Target 16,1%
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Managers and Directors
David A. Ricks Chairman, President & Chief Executive Officer
Anat Ashkenazi Chief Financial Officer & Senior Vice President
Timothy J. Garnett Chief Medical Officer & VP-Global Medical
Daniel M. Skovronsky Chief Scientific Officer & Senior Vice President
Diogo Rau Senior VP, Chief Information & Digital Officer
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