{"id":474174,"date":"2021-04-09T08:18:35","date_gmt":"2021-04-09T12:18:35","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=474174"},"modified":"2021-04-09T08:18:35","modified_gmt":"2021-04-09T12:18:35","slug":"nih-covid-19-treatment-guidelines-strongly-recommend-use-of-regen-cov-casirivimab-with-imdevimab-in-outpatients-at-high-risk-of-clinical-progression","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nih-covid-19-treatment-guidelines-strongly-recommend-use-of-regen-cov-casirivimab-with-imdevimab-in-outpatients-at-high-risk-of-clinical-progression\/","title":{"rendered":"NIH COVID-19 Treatment Guidelines Strongly Recommend Use of REGEN-COV\u2122 (casirivimab with imdevimab) in Outpatients at High Risk of Clinical Progression"},"content":{"rendered":"
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Some panel members also recommended preferential use of REGEN-COV antibody cocktail in regions where certain variants are common<\/h2>\n

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

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\n TARRYTOWN, N.Y.<\/span>, April 9, 2021<\/span> \/PRNewswire\/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN<\/b>) announced today that newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines<\/a> strongly recommend that REGEN-COV\u2122 (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients (“outpatients”)\u00a0at high risk of clinical progression. The Category ‘AIIa’ is a ‘strong’ rating based on results of randomized trials.<\/p>\n

The recommendation from the NIH COVID-19 Treatments Guidelines Panel is a critical step in helping make monoclonal antibody therapies like REGEN-COV available for all appropriate patients\u00a0in the U.S. The new guidelines are based in part on robust clinical data involving more than 4,500 outpatients<\/a>\u00a0showing that REGEN-COV significantly reduced the risk of hospitalization or death by 70% compared to placebo.<\/p>\n

“With these clear new NIH guidelines, Emergency Use Authorization from the U.S. Food and Drug Administration,\u00a0ample supply of REGEN-COV,\u00a0and the medicine being supplied free of charge by the U.S. government, the time for equivocation has passed \u2014 we must now all do whatever it takes to make sure appropriate patients are treated as early as possible after diagnosis,”\u00a0<\/i>said Leonard S. Schleifer<\/span>, M.D., Ph.D., President and CEO at Regeneron. “If we work together, we can avoid tens of thousands of needless hospitalizations or deaths from COVID-19. We will also continue to partner with stakeholders to address other key bottlenecks such as education, ease of administration and better systems to ensure infusion reimbursement.”<\/p>\n

Despite the strong progress being made with vaccination, in the U.S. approximately 2 million people a month are still diagnosed with COVID-19 and tens of thousands are at risk of dying from COVID-19.<\/p>\n

Importantly,\u00a0some\u00a0NIH panel\u00a0members recommended REGEN-COV as the preferred antibody cocktail for COVID-19 in areas where variants are common, given REGEN-COV’s continued potency in vitro<\/i> against the variants first identified in the United Kingdom<\/span>, Brazil<\/span>, South Africa<\/span>, New York<\/span> and California<\/span>, while acknowledging that it is not known whether in vitro <\/i>susceptibility data correlates with clinical outcomes. The U.S. Food and Drug Administration (FDA) recently authorized<\/a> updated Emergency Use Authorization (EUA) fact sheets for all authorized monoclonal antibody treatments, which indicate that REGEN-COV is the only therapy to retain potency against these key emerging variants. In many parts of the U.S., variants now make up the majority of all new COVID-19 cases.<\/p>\n

“Regeneron continues to innovate to respond to this devastating pandemic. With approximately 60,000 new infections daily, many of them in high-risk individuals, it’s clear there is an urgent need to improve access to treatments like REGEN-COV that are proven to reduce hospitalization or death,”\u00a0said George D. Yancopoulos<\/span>, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “In addition to working to advance simpler subcutaneous administration of REGEN-COV, we look forward to sharing additional data soon on the use of REGEN-COV to prevent infection.”<\/p>\n

Although REGEN-COV is not currently recommended for people hospitalized due to COVID-19, the panel recommended that REGEN-COV use should be considered for persons with mild-to-moderate COVID-19\u00a0who are hospitalized for a reason other than COVID-19 but who otherwise meet the EUA criteria.<\/p>\n

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.<\/p>\n

\n About the REGEN-COV Antibody Cocktail
<\/b>REGEN-COV (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron’s proprietary VelocImmune\u00ae<\/sup><\/i> and VelociSuite\u00ae<\/sup><\/i> technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science<\/a><\/i>.<\/p>\n

Under an EUA issued<\/a>\u00a0by the FDA, REGEN-COV is currently available in the U.S. to treat mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and\/or hospitalization. REGEN-COV has not been approved by FDA but has been authorized for emergency use. This use is authorized 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

REGEN-COV is currently authorized and available in a 2,400 mg IV dose, with infusion times as short as 20 minutes. The criteria for ‘high-risk’ patients are described in the\u00a0Fact Sheet for Healthcare Providers<\/a>. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.<\/p>\n

Under this EUA, REGEN-COV is available throughout the U.S. \u2013 information on availability in your area is available from the Department of Health and Human Services<\/a> and the National Infusion Center Association<\/a>.<\/p>\n

Regeneron is collaborating<\/a>\u00a0with Roche to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.<\/p>\n

\n About Regeneron’s VelocImmune<\/i> Technology
<\/b>Regeneron’s VelocImmune<\/i> technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos<\/span> was a graduate student with his mentor Frederick W. Alt<\/span> in 1985, they were the first to\u00a0envision<\/a>\u00a0making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune<\/i> and related VelociSuite<\/i> technologies. Dr. Yancopoulos and his team have used VelocImmune<\/i> technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COVTM<\/sup> (casirivimab with imdevimab), Dupixent\u00ae<\/sup> (dupilumab), Libtayo\u00ae<\/sup> (cemiplimab-rwlc), Praluent\u00ae<\/sup> (alirocumab), Kevzara\u00ae<\/sup> (sarilumab), Evkeeza\u2122 (evinacumab-dgnb) and Inmazeb\u2122 (atoltivimab, maftivimab and odesivimab-ebgn).<\/p>\n

\n AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION<\/b>\n <\/p>\n

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\n Authorized Emergency Use
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\n <\/b>REGEN-COV, (casirivimab with imdevimab to be administered together) is 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 progressing to severe COVID-19 and\/or hospitalization. [see Limitations of Authorized Use]<\/p>\n