{"id":403120,"date":"2020-12-18T17:03:20","date_gmt":"2020-12-18T22:03:20","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=403120"},"modified":"2020-12-18T17:03:20","modified_gmt":"2020-12-18T22:03:20","slug":"lilly-to-begin-pragmatic-study-of-neutralizing-antibody-bamlanivimab-ly-cov555-for-covid-19-in-new-mexico","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lilly-to-begin-pragmatic-study-of-neutralizing-antibody-bamlanivimab-ly-cov555-for-covid-19-in-new-mexico\/","title":{"rendered":"Lilly to begin pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico"},"content":{"rendered":"
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Study will provide real-world data and insight on various infusion setting experiences<\/h2>\n

Plan to study bamlanivimab in a diverse group of participants, including Native American communities<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n INDIANAPOLIS<\/span>, Dec. 18, 2020<\/span> \/PRNewswire\/ —\u00a0Eli Lilly and Company (NYSE: LLY) today announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, in collaboration with major local institutions in the state of New Mexico<\/span>. Conducting the study in New Mexico<\/span> will allow for the collection of data on the effectiveness and safety of bamlanivimab in a real-world setting that includes a diverse population and spans both rural and urban environments. <\/p>\n

Bamlanivimab recently received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and\/or hospitalization. <\/p>\n

“It is important to continue building on the evidence base for bamlanivimab through ongoing studies, including those in a real-world setting,” said Daniel Skovronsky<\/span>, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “In addition to gathering treatment and safety data, Lilly will use this study to explore the delivery of bamlanivimab in a variety of innovative infusion settings, which could help inform best practices and ultimately replication by institutions around the country.”<\/p>\n

The study will begin in the coming weeks and will evaluate the effectiveness of bamlanivimab in reducing COVID-19 hospitalizations in a high-risk population. Under the study design, a variety of infusion settings will be utilized across the state, allowing access to multiple diverse communities \u2013 including Native American communities.\u00a0As part of this study, Lilly will employ its unique mobile research units used successfully in other studies. These units include a custom retrofitted recreational vehicle (RV) solution to support mobile labs and clinical trial material preparation, along with a support vehicle to deliver all clinical trial supplies needed to create an on-site infusion clinic for patients who may otherwise not be able to participate in a clinical study due to lack of access.<\/p>\n

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\n Important Information about bamlanivimab\u00a0<\/u>
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Bamlanivimab has not been approved by the FDA for any use.\u00a0 It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.\u00a0 <\/p>\n

Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.<\/p>\n

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization<\/a>, Fact Sheet for Healthcare Providers<\/a>, and Fact Sheet for Patients, Parents, and Caregivers\u00a0(English<\/a>) (Spanish<\/a>).<\/p>\n

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\n Authorized Use and Important Safety Information
<\/u>
\n <\/b>Bamlanivimab 700 mg injection is authorized for use under an EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and\/or hospitalization.<\/p>\n

\n Limitations of Authorized Use<\/b>\n <\/p>\n