
<p><strong><span class="has-inline-color has-vivid-red-color">TOPLINE</span></strong> The Food and Drug Administration Thursday <a rel="noreferrer noopener" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19" target="_blank">issued</a> an emergency use authorization for Eli Lilly’s rheumatoid arthritis drug baricitinib and remdesivir for coronavirus treatment, the first drug combination authorized by the FDA as a therapeutic for the virus. </p>



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<p>Baricitinib is an existing FDA-approved drug for rheumatoid arthritis, but it has benefits for coronavirus patients used in combination with Gilead Sciences’ remdesivir, which has already been given&nbsp;<a href="https://www.forbes.com/sites/rachelsandler/2020/10/22/fda-approves-remdesivir-for-covid-19-treatment/?sh=680206fe63c8">full FDA approval</a>.</p>



<p>The emergency authorization only applies to hospitalized patients in need of supplemental oxygen.</p>



<p>The drug combination was given emergency approval based on a randomized double-blind trial that found it reduced median recovery time by one day and increased the chances of survival by 35% compared to patients taking remdesivir alone.</p>



<p>Scientists are also interested in the combination of baricitinib and the steroid dexamethasone, the latter of which was taken by President Donald Trump when he was infected, as a potential coronavirus therapeutic.&nbsp;</p>



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<p>“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.&nbsp;</p>



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<p>&nbsp;Eli Lilly has also earned emergency approval for bamlanivimab, a monoclonal antibody treatment for early cases of Covid-19. Other promising therapeutics, including Regeneron’s antibody cocktail and dexamethasone have yet to receive FDA approval. Hydroxychloroquine had its emergency authorization rescinded after data showed it had no benefit for Covid-19 patients.</p>



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<p>Eli Lilly is conducting a clinical trial for baricitinib by itself, and the company may pursue an emergency use authorization for the drug depending on the results.</p>



<p><em>-By Rachel Sandler, Forbes Staff</em></p>


Pharmaceutical research into infectious disease and pandemics, scientist pipetting a sample of a new drug formula into a vial during a clinical trial with the infectious disease on the computer screen

FDA Gives Emergency Approval To Covid-19 Treatment That Combines Eli Lilly Arthritis Drug With Remdesivir


<p>The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.</p>



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<p>The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.</p>



<p>Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.</p>



<p>The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.</p>



<p>Clinical trial data has been mixed: A&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT04292730" target="_blank" rel="noreferrer noopener">randomized</a>&nbsp;trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed,&nbsp;<a href="https://www.forbes.com/sites/mattperez/2020/10/15/antiviral-drug-remdesivir-proves-ineffective-in-treating-covid-19-who-study-finds/#ff60bb95d01d">found</a>&nbsp;last week the drug did not increase the chances of survival or result in faster recovery.</p>



<p>Gilead shares jumped 3.8% in after hours trading following the announcement.&nbsp;</p>



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<p>“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead CEO Daniel O’Day in a statement.</p>



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<p>President Donald Trump took remdesivir when being treated for the coronavirus earlier this month.</p>



<p>&#8211;<em>By Rachel Sandler, Forbes Staff</em></p>


Tag: Remdesivir

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FDA Gives Emergency Approval To Covid-19 Treatment That Combines Eli Lilly Arthritis Drug With Remdesivir

FDA Approves Remdesivir For Covid-19 Treatment