{"id":539288,"date":"2021-09-16T16:00:09","date_gmt":"2021-09-16T20:00:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/emergency-use-authorization-for-lillys-bamlanivimab-and-etesevimab-administered-together-expanded-to-include-post-exposure-prophylaxis-for-covid-19\/"},"modified":"2021-09-16T16:00:09","modified_gmt":"2021-09-16T20:00:09","slug":"emergency-use-authorization-for-lillys-bamlanivimab-and-etesevimab-administered-together-expanded-to-include-post-exposure-prophylaxis-for-covid-19","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/emergency-use-authorization-for-lillys-bamlanivimab-and-etesevimab-administered-together-expanded-to-include-post-exposure-prophylaxis-for-covid-19\/","title":{"rendered":"Emergency Use Authorization for Lilly’s bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19"},"content":{"rendered":"
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Expanded emergency use authorization includes certain people who have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting<\/h2>\n

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

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\n INDIANAPOLIS<\/span>, Sept. 16, 2021<\/span> \/PRNewswire\/ —\u00a0The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 infection, Eli Lilly and Company (NYSE: LLY) announced today. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison. This authorization follows the national reopening of distribution earlier this month<\/a>.<\/p>\n

“Despite very significant improvements to public health resulting from COVID-19 vaccination, with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals, including nursing home residents and individuals with medical conditions that put them at high risk for the most severe outcomes,” said Daniel Skovronsky<\/span>, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. “We’re pleased that this expansion will help us provide antibody therapies as post-exposure prophylaxis to help prevent the spread of COVID-19 to some of the most at-risk individuals in the U.S.”<\/p>\n

The expanded authorization is based on data from BLAZE-2, a study conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN), that enrolled residents and staff at long-term care facilities, commonly referred to as nursing homes, across the U.S. In this placebo-controlled Phase 3 study,\u00a0bamlanivimab\u00a04200 mg\u00a0reduced\u00a0the risk of contracting symptomatic COVID-19 by up to 80 percent\u00a0in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.<\/p>\n

“Recent\u00a0reports\u00a0suggest that fully vaccinated residents of nursing homes have\u00a0contracted COVID-19, some of whom became quite ill,” said Myron Cohen<\/span>, M.D., director of UNC’s<\/span> Institute for Global Health and Infectious Diseases and a CoVPN leader. “This additional emergency use authorization of monoclonal antibodies for post-exposure prophylaxis in addition to the treatment of COVID-19 offers a significant achievement in the fight against this pandemic.”<\/p>\n

Since the beginning of the pandemic, Lilly has mobilized the company’s scientific and medical expertise to fight this terrible disease. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to be granted emergency use authorization from the FDA as a treatment for mild to moderate COVID-19 \u2014 providing a valuable therapy at a time in the U.S. when cases were increasing to their highest level. Lilly now only supplies bamlanivimab and etesevimab together in the U.S.<\/p>\n

“In just months, Lilly achieved what usually takes years by bringing multiple therapies to patients under emergency use authorizations,” continued Skovronsky. “Since then, over 535,000 treatment courses of bamlanivimab or bamlanivimab and etesevimab together have been administered to patients, potentially preventing more than\u00a025,000 hospitalizations and 10,000 deaths during the worst of the pandemic in the U.S.”<\/p>\n

Pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Alpha and Delta variants. On September 2<\/span>nd<\/sup>, the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the U.S. Food and Drug Administration (FDA), resumed the shipment and distribution of bamlanivimab and etesevimab administered together. <\/p>\n

For more information about the use of bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 and prevention of COVID-19 in high-risk patients under the\u00a0FDA’s\u00a0emergency use authorization, please see the Fact Sheet for Healthcare Providers<\/a>, and Fact Sheet for Patients, Parents and Caregivers (English<\/a>) (Spanish<\/a>), click here<\/a>\u00a0or contact\u00a0Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit\u00a0the NICA Infusion Center Locator\u00a0<\/a>or the\u00a0HHS Therapeutics Distribution locator<\/a>\u00a0to find a potential therapy location.<\/p>\n

For media resources, including product images and fact sheets, please click\u00a0here<\/a>.<\/p>\n

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\n Important Information about bamlanivimab and etesevimab together
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\n <\/b>Bamlanivimab and etesevimab together have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together are\u00a0safe and effective for the treatment or post-exposure prophylaxis of COVID-19.\u00a0<\/p>\n

Bamlanivimab and etesevimab together are\u00a0authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use 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 etesevimab together and mandatory requirements of the EUA. Please see the\u00a0FDA Letter of Authorization<\/a>,\u00a0Fact Sheet for Healthcare Providers<\/a>, and Fact Sheet for Patients, Parents and Caregivers (English<\/a>) (Spanish<\/a>) for bamlanivimab and etesevimab together.<\/p>\n

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\n Authorized Use and Important Safety Information<\/i>
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\n TREATMENT<\/b>\n <\/p>\n

Bamlanivimab and etesevimab together are authorized for the treatment of mild to moderate coronavirus disease 2019 (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 progression to severe COVID-19, including hospitalization or death.<\/p>\n

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

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\n Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab<\/i>
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