Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and their Administration During the Public Health Emergency: EVUSHELD isnt currently authorized for emergency use in the U.S. Jan - Dec 2022 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP). Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Early-stage clinical trial results may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Merck . Answer: Sotrovimab (Xevudy), developed by GlaxoSmithKline and Vir Biotechnology, is the second monoclonal antibody (mAb) to be approved for the treatment of COVID-19 infection (MHRA 2021) and the first to show activity against all SARS-CoV-2 variants of concern tested, including Mu (B.1.621), Omi. After entering your body, monoclonal antibodies find and bind to the spike protein of the SARS-CoV-2 virus, which causes COVID-19. Monoclonal antibodies such as those made by Regeneron and GlaxoSmithKline won't work for every Covid-19 patient; mAbs, as they are known, are only available for people age 12 and older and who . The significant known and potential risks and benefits of sotrovimab and the extent to which such risks and benefits are unknown. Do not administer simultaneously with any other medications; compatibility with IV solutions and medications other than 0.9% NaCl is unknown. The Company stated: in the U.S. alone, millions of immuno-compromised people will not adequately respond to vaccination. Find out more, Markets approach mini-Budget madness levels ahead of Hunt's Spring Statement, How Tesco and Sainsbury's obsession with Aldi fuelled Britain's fruit and vegetable rationing crisis, British chipmakers hold talks with White House amid Biden charm offensive, Germany and Italy block Brussels from banning petrol and diesel cars, Students to be allowed to use ChatGPT for GCSE and A-level exams under Whitehall plans, Covid antibody treatment from GlaxoSmithKline. Update [3/25/2022] FDA limits use of Sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant. FDA has authorized the emergency use of sotrovimab for the 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 progression to severe COVID-19, including hospitalization or death. This EUA for sotrovimab will end when the Secretary determines that the circumstances justify the EUA no longer exist or when there is a change in the approval status of the product such that an EUA may no longer be needed. The new drug has been described by the Medicines and Healthcare products Regulatory Agency as 'another significant step forward in our fight against Covid-19' how fast does sotrovimab work. CNN . how much does sotrovimab cost uk. For providers and suppliers with payments that are geographically adjusted by the methodology used by the Medicare Physician Fee Schedule (MPFS), files with the geographically adjusted payment rates for monoclonal antibody administration are included in the Additional Resources section below. Subject: Paxlovid, Molnupiravir, Sotrovimab Appear Cost Effective To ICER; But Data, Price Could Change Add a personalized message to your email. how much does sotrovimab cost uk. To enroll, go to https://covid-pr.pregistry.com or call 1-800-616-3791 to obtain information about the registry. Health and Social Care Secretary Sajid Javid said: This latest deal further reflects the UKs fantastic track record for finding the worlds best Covid-19 treatments for example, dexamethasone, which has saved tens of thousands of lives in England alone. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Store in a refrigerator (28) and protect from lightconsult product literature about storage after dilution. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These resources are designed to increase the number of providers that can administer the products and ensure adequate reimbursement for administration in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover these products at no charge to beneficiaries. In a clinical trial, it was found that a single dose of sotrovimab was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic Covid-19 infection. An interim analysis reported that COVID-19 had progressed in 3/291 patients infused with sotrovimab and 21/292 given a placebo. It was carefully selected for its demonstrated promise in preclinical research and potential ability to both block the virus from entering healthy cells and clear infected cells. Last month, the NHS said it would start offering patients the treatment, which is a combination of two monoclonal antibodies. There are no available data on the presence of sotrovimab in human milk, the effects on the breastfed infant, or the effects on milk production. NHS England Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies for non-hospitalised patients with COVID-19 (available at: https://www.england.nhs.uk/coronavirus/publication/interim-clinical-commissioning-policy-neutralising-monoclonal-antibodies-or-antivirals-for-non-hospitalised-patients-with-covid-19/). Essendon Member Discounts, Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. As the healthcare provider, you must communicate to yourpatient or parent/caregiver, as age appropriate, information consistent with theFact Sheet for Patients, Parents, and Caregivers (and provide a copy of the Fact Sheet) prior to the patient receiving sotrovimab, including: For information on clinical trials that are testing the use of sotrovimab for COVID-19, please see www.clinicaltrials.gov. minnesota wild vs colorado avalanche prediction; north tyneside council envirolink; smartview2 system menu pin; high speed gear handcuff taco kydex; how much does sotrovimab cost uk. It can also be administered to pediatric patients over 12 years of age and weighing at least 40 kgs. She said as the world moved into the endemic phase, vaccines and treatments would need to work in a complementary fashion. 1. . Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the US Securities and Exchange Commission, including the section titled Risk Factors contained therein. Monitor breast-fed infants for adequate feeding and hypersensitivity reactions. Treatment began within five days of the start of symptoms. The drug was 100 per cent successful in preventing deaths and 99 per cent effective in stopping admissions to intensive care . There is a 10-day window to get the treatment after symptom onset, according to the Centers for . HCPCS Q0249, M0249 and M0250 are billable on TOB 12X (inpatient hospital only). Sotrovimab is not FDA-approved and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. About sotrovimab. [11] On November 30, 2022, the FDA announced that bebtelovimab isnt currently authorized in any U.S. region because it isnt expected to neutralize Omicron sub-variants BQ.1 and BQ.1.1. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. This statement updates and replaces the original statement below from 2 . require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen. Sign up to get the latest information about your choice of CMS topics. Eligibility requirements vary for each program. The free Drugs.com Discount Card works like a coupon and can save you up to The prescribing healthcare provider and/or the providers designee must report all serious adverse events and medication errors potentially related to sotrovimab within 7 calendar days from the healthcare providers awareness of the event by (1) submitting FDA Form 3500 online at http://www.fda.gov/medwatch/report.htm; (2) downloading FDA Form 3500 (https://www.fda.gov/media/76299/download) and then mailing or faxing (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; or fax 1-800-FDA-0178); or (3) contacting the FDA at 1-800-FDA-1088 to request this form. About global access to sotrovimab. Recevoir Sms En Ligne Canada, Patients treated with sotrovimab should continue to self-isolate and use infection control measures (eg, wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. 4; You are leaving the GSK sotrovimab site to visit a separate website. dewitt thompson v net worth. Secure .gov websites use HTTPSA In addition, please provide a copy of all FDA MedWatch forms to: GlaxoSmithKline, Global Safety; Fax: 919-287-2902; Email: WW.GSKAEReportingUS@gsk.com; Or call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) to report adverse events. how much does sotrovimab cost uk. 600,000 additional doses to be supplied to the US Government for distribution in Q1 2022, enabling further access to sotrovimab nationwide; . Therefore, you may not administer bebtelovimab to treat COVID-19 under the EUA until further notice. Sotrovimab is authorized for use under an Emergency Use Authorization (EUA), so there is no dispute, and it is 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 . More than 4.8 million persons worldwide have died from coronavirus disease 2019 (Covid-19) during the global pandemic. The five patients who subsequently needed intensive care were all from the placebo group. Accessed March 28, 2022.https://www.fda.gov/media/149534/download, To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Last December the UK's Medicines and Healthcare Products Regulatory Agency approved sotrovimab for people aged over 12 with mild to moderate covid-19 who were at high risk of developing severe disease, after it was shown to reduce the risk of hospital admission and death by 79% in high risk adults with symptomatic covid-19. south bend fire department news. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency. how much does sotrovimab cost uk. Pearson said the pandemic has lots of "moving parts" and if the risk of hospitalization from infection with Omicron or a future variant proves to be lower, ICER's analysis would change. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Shares of Vir Biotechnology ( VIR -1.12%) were sinking 18.1% for the week as of the market close on Thursday. This website links to third-party sites. On May 5, 2022, the FDA limited the authorized use of the Janssen COVID-19 vaccine. The most recent research from the CDC suggests that protection from the Pfizer and Moderna COVID-19 vaccines starts to fade around 4 months after a booster dose. 8 " The earlier, the better," Ginde said. (tixagevimab co-packaged with cilgavimab): Part B Biosimilar Biological Product Payment and Required Modifiers. A recent clinical trial has studied how well Sotrovimab works in treating COVID-19. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, successful development and/or commercialization of alternative product candidates by Virs competitors, changes in expected or existing competition, delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. All quotes delayed a minimum of 15 minutes. The cost of Regeneron's two-drug cocktail is $1,250 per infusion, according to Kaiser Health News. . Note: This is a drug discount program, not an insurance plan. Pseudotyped virus-like particle neutralization data of Sotrovimab (May 2021) B.1.1.7 (UK origin): No change: less than 5-fold reduction in susceptibility; B.1.351 (South . There are limited clinical data available for sotrovimab. Heres how you know. You'll only need 1 dose. [10] [11] [12] It was developed by GlaxoSmithKline and Vir Biotechnology, Inc. [11] [13] Sotrovimab is designed to attach to the spike protein of SARS-CoV-2. It first . This final draft guidance provides recommendations to the UKs National Health Service on the future routine commissioning of therapeutics for people with COVID-19 while COVID-19 is an endemic disease. Limitations of Benefit and Potential for Risk in Patients with Severe COVID19. how much does sotrovimab cost uk. Listed as of 1 March, GPs can now prescribe molnupiravir (sold as Lagevrio), which will be available to patients for $42.50 per script - or $6.80 for concession card holders. June 7, 2022 . Before the summer surge, Regeneron was shipping fewer than 25,000 doses per week, rising to more than 130,000 doses per week by mid August. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Drug Profile Sotrovimab - GlaxoSmithKline/Vir Biotechnology Alternative Names: GSK-4182136; VIR-7831; WBP 2275; Xevudy Latest Information Update: 24 Feb 2023 Price : $50 * Buy Profile Adis is an information provider. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab monoclonal antibody (MAB) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing . Long, medium, and short descriptors of COVID-19 CPT codes are available from AMA website. how much is parking at calamigos ranch? Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Medicines and Healthcare products Regulatory Agency (MHRA), UK on December 31, 2021. *The healthcare provider should visit https://clinicaltrials.gov to determine whether there is an active clinical trial for the product in this disease/condition and whether enrollment of the patient(s) in a clinical trial is more appropriate than product use under this EUA. The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.[Continue Reading]. FACT SHEET FOR US HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET FOR US HEALTHCARE PROVIDERS (SPANISH), FACT SHEET - HEALTHCARE PROVIDERS (ENGLISH), FACT SHEET - HEALTHCARE PROVIDERS (SPANISH), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents, and Caregivers, Fact Sheet for Patients, Parents, and Caregivers (English), Fact Sheet for Patients, Parents, and Caregivers (Spanish), https://www.fda.gov/media/149534/download, https://www.fda.gov/media/149533/download, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency [see. increased risk for progression to severe COVID-19. With this recommendation, sotrovimab continues to be an important option for appropriate patients around the world and we remain committed to working with our partner GSK to ensure patients in need have access to it.. Let's look at two excellent options in the healthcare sector: Merck ( MRK -1.25%) and Vir Biotechnology ( VIR -2.12%). The Department for Health and Social Care has bought 100,000 doses of the treatment, called sotrovimab, which has yet to be approved by UK regulators but has been given the green light in the. Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. IV Compatibilities. While the vaccination programme continues to protect millions, its vital we keep securing the most cutting-edge treatments for this disease to protect as many people as possible for years to come., The Telegraph values your comments but kindly requests all posts are on topic, constructive and respectful. CMS has released a set of toolkits for providers, states and insurers to help the health care system prepare and assist in swiftly administering these products once they become available. An official website of the United States government Issued: London, UK and San Francisco, US. Quality Seeds For Farmers Wealth Creation The federal . how much does sotrovimab cost uk. Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. The data supporting this EUA for sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild . One reaction led to temporary pausing of the infusion. The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen . As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. The treatment has yet to be approved by UK regulators but has been given the green light in the US, the EU and Japan. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus' attachment and entry into human cells. As a result, CMS issued a new product code for casirivimab and imdevimab (Q0244) and updated the descriptors for the existing administration codes (M0243/M0244). The FDA explained that sotrovimab was found to be ineffective against the Omicron BA.2 subvariant that is estimated to be responsible for more than half of all current U.S. COVID-19 cases. [5]On June 3, 2021, the FDA revised the EUA for casirivimab and imdevimab to change the allowed dosing regimen from 2400 mgto 1200 mg, and allow providers to administer the combination product by subcutaneous injection in limited circumstances. It's called sotrovimab, and scientists say preliminary checks suggest it should work well . Sotrovimab is under review by UK regulators. Unlike molnupiravir, which is taken orally, sotrovimab is. Newsletter: Decoded . Both Pfizer and Moderna upped European prices for their products this year; the EU will now pay $23.15 per dose of Pfizer's jab (up from $18.40), while Moderna is charging $25.50 for doses that previously cost around $22.60. See here for a complete list of exchanges and delays. Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency. FDA has authorized the emergency use of sotrovimab for the 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 progression to severe COVID-19, including hospitalization or death. A single dose of sotrovimab is administered through an injection or an IV as soon as someone tests positive for COVID. [1]Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date. Branded Ronapreve in the UK and REGEN-COV in the US, the drug was developed by Regeneron Pharmaceuticals with Roche. It works by attaching itself to the spike protein on the outside of the Covid-19 virus which in turn prevents the virus from attaching to and entering human cells, and therefore cannot replicate in the body. Of the estimated 2 million people with long covid, 1.4 million are thought to have been infected, or suspect they were infected, at least 12 weeks prior to their ongoing symptoms. 0 . But it is used only in patients with mild to moderate symptoms. It can also be administered to pediatric patients over 12 years of age and weighing at least 40 kgs. REGEN-COV has a list price of about $1,250 per dose, while sotrovimab is more than $2,000 per dose, although Regeneron's product is free to patients as the bill is paid by the federal government. 3; The European Medicines Agency (EMA) on November 19, 2021. means youve safely connected to the .gov website. Jan - Dec 2023 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration, Jan - Dec 2023 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration, Jan - Dec 2022 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), Jan - March 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), March - Dec 2021 Geographically-adjusted Payment Rates for COVID-19 Vaccine Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), Jan-May 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), May-Dec 2021 Geographically-adjusted Payment Rates for Monoclonal Antibody Administration (for Providers & Suppliers Paid MPFS-Adjusted Rates) (ZIP), Monoclonal Antibody Emergency Use Authorizations (EUAs) & Fact Sheets, Vaccine Authorization Letters & Fact Sheets, Pfizer-BioNTech COVID-19 Vaccine, Bivalent Product (Aged 12 years and older) (Gray Cap), Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Gray Cap) Administration Booster Dose, Moderna COVID-19 Vaccine, Bivalent Product (Aged 12years and older) (Dark Blue Cap with gray border), Moderna COVID-19 Vaccine, Bivalent (Aged 12years and older) (Dark Blue Cap with gray border) Administration Booster Dose. The US Food and Drug Administration has issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40kgs) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19 . It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID19. Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness, and diaphoresis. These reactions may be severe or life threatening. How much does it cost? The dose of sotrovimab is 500mg. Meanwhile . Cancel . [6]On July 30, 2021, the FDA revised the EUA for casirivimab and imdevimab to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. By Posted split sql output into multiple files In tribute to a mother in twi Available for Android and iOS devices. Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration. Official websites use .govA Large molecular weight suggests limited excretion into milk. That leaves one COVID-19 treatment available to treat omicron infections, and in early December, GlaxoSmithKline (GSK) announced that its sotrovimab monoclonal antibody "retains in vitro . June 3, 2022 Posted by: Category: Uncategorized; No Comments . It was carefully selected for its demonstrated promise in preclinical research and potential ability to both. 0.9% NaCl. Sotrovimab is an engineered human immunoglobulin G (IgG)1 monoclonal antibody (mAb) that binds to a highly conserved epitope on the spike protein receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high affinity (dissociation constant Kd = 31 ng/mL). The UK's medicines agency (MHRA) has approved a treatment for COVID-19 that has been found to cut hospitalisation and death by 79 per cent. Sotrovimab is not authorized in the US. Sotrovimab, sold under the brand name Xevudy, cuts the risk of hospitalisation by 79 per cent among those at risk from the virus. Sotrovimab for Early Covid-19. https:// The Pfizer and Merck drugs are meant to be taken at home, while GSK's antibody is administered in hospital or infusion centers. "Once you are hospitalized, it's too late.". [5] On June 3, 2021, the FDA revised the EUA for casirivimab and imdevimab to change the allowed dosing regimen from 2400 mg to 1200 mg, and allow providers to administer the combination product by subcutaneous injection in limited circumstances. dababy white teeth Uncategorized how much does sotrovimab cost uk. M. Sotrovimab is a biological medicine. If the treatments were used in lower-risk populations, "their cost effectiveness would be significantly reduced," ICER said. More in Sotrovimab (Xevudy) Were the sotrovimab . Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Final gross price and currency may vary according to local VAT and billing address. A full 8-milliliter dose of sotrovimab will cost roughly $2000, which is far from a competitive price point compared to other existing and emerging treatments for Covid-19. HCPCS Q0220, M0220, and M0221 billable on the following TOBs: 12X, 13X, 22X, 23X, 34X, 72X, 75X, 81X, 82X and 85X. Vir routinely posts information that may be important to investors on its website. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to sotrovimab during pregnancy. how much does sotrovimab cost uk . In response, the FDA has issued this EUA, as requested by GlaxoSmithKline, for the unapproved product, sotrovimab, for the 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 progression to severe COVID-19, including hospitalization or death. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use. It was carefully selected for its demonstrated promise in preclinical research and potential ability to both block the virus from entering healthy cells and clear infected cells. Virs Commitment to COVID-19Vir was founded with the mission of addressing the worlds most serious infectious diseases. For media and investors only.