Sotrovimab (Xevudy) Brand name: Xevudy. Shares of Vir Biotechnology ( VIR -1.12%) were sinking 18.1% for the week as of the market close on Thursday. The WHO has identified four Covid variants of concern. 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. The most common side effects with sotrovimab are rash and diarrhoea. See here for a complete list of exchanges and delays. 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 . is a member of the miscellaneous antivirals drug class and is commonly used for Weve signed the contract for this novel and promising Covid-19 treatment to strengthen our armoury of therapeutics and to ensure it can be rolled out to patients as quickly as possible, should it be approved by our medicines regulator. 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. 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. Certain settings utilize other payment methodologies, such as payment based on reasonable costs. Sotrovimab has officially been approved for use in the UK (Photo: PA) Who can and cannot have it. By Posted split sql output into multiple files In tribute to a mother in twi Newsletter: Decoded . The deal is subject to approval. We'll take our total purchase of sotrovimab, which is, as I say, the monoclonal antibody, the treatment that's been used for patients that might graduate from mild to moderate to very severe conditions and we'll now have a total of 81,000 units available with these additional 46,000. Sotrovimab, with the brand name Xevudy, is the second. Sotrovimab has been granted a provisional marketing authorisation in Australia . The most common side effects are nausea, dizziness, and an itchy rash, redness, or warmth on the skin. How and when to have it. 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. 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 US, the EU and Japan. 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. June 4, . Duane Reade and 65,000 pharmacies nationwide. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Therefore, sotrovimab is not authorized for use in adults and pediatric patients who are hospitalized due to COVID19, OR who require oxygen therapy and/or respiratory support due to COVID19, OR who require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen. Clinically monitor patients for at least 1 hour after completion of the infusion for signs and symptoms of hypersensitivity. The latter's American-made vaccine is considerably cheaper in the US, where each dose costs about $15, while . Sotrovimab is a new anti-viral therapy that has been approved for use on patients aged 12 years or more with severe attack of COVID-19. Sotrovimab is not authorized in the US. [1]Providers shouldn't bill for the product if they received it for free through the USG-purchased inventory. This website links to third-party sites. M. Specialist sources indicate use with cautionno information available. Meanwhile . About global access to sotrovimab. Do not administer simultaneously with any other medications; compatibility with IV solutions and medications other than 0.9% NaCl is unknown. This price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. Following links contain helpful information for providers. It is vitally important that, alongside vaccines, we have treatments available that can help stop progression to severe disease in patients at high risk from the infection.". On top of that, we add a fee to cover the cost of our services, enabling us to continue functioning as a social enterprise. Important Information About Sotrovimab. In an attempt to study the safety and effectiveness of sotrovimab in more vulnerable patients suffering from mild to moderate symptoms of COVID-19, a multinational team of researchers conducted . Providers should not bill for the product if they received it for free. It is a monoclonal antibody therapy developed by. For sotrovimab For intravenous infusion (Xevudy), dilute in 50 mL or 100 mL Glucose 5% or Sodium Chloride 0.9% and administer over 30 minutes through an in-line 0.2 micron filter. SAN FRANCISCO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the UKs National Institute for Health and Care Excellence (NICE) provided positive final draft guidance recommending the use of sotrovimab, an investigational SARS-CoV-2 neutralizing monoclonal antibody, in adults who do not need supplemental oxygen for COVID-19 and who have an increased risk for progression to severe COVID-19 where nirmatrelvir/ritonavir (Paxlovid) is contraindicated or unsuitable. You can decide how often to receive updates. While Noom does advertise a free one-week trial, a subscription costs up to $59 a month. Sotrovimab is a prescription medication used to treat mild-to-moderate Coronavirus disease 2019 (COVID-19). Heres how you know. Qualitative and quantitative composition. GlaxoSmithKline's Amanda Peppercorn said: We are facing a situation where the world may well have to live with Covid-19 for some time and the reality is that many may continue to be at risk. 8 " The earlier, the better," Ginde said. *As a healthcare provider, you must comply with the mandatory requirements of this EUA. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID19. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. [6] On October 12, 2022, the FDA authorized the Moderna bivalent product (dark blue cap with gray border) and its administration for use as a single booster dose in individuals 12 years through 17 years of age in addition to the 8/31/2022 FDA authorization as a single booster dose in individuals 18 years and older. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Cancel . NICE 2023. It may be used in some circumstances but Paxlovid, remdesivir and molnupiravir are usually used instead. 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. Merck's COVID treatment drug, molnupiravir, has only passed the first hurdle towards approval in Australia but the federal government has bought 300,000 doses after some promising preliminary results. does msi optix g27c4 have speakers; gated communities in mountain brook, al; italian bocce team names; wishbone california onion salad dressing; 0; different ways by which society and culture shape the self. The federal government is covering the cost of the monoclonal antibody therapies, so it is free to get, but . Long, medium, and short descriptors of COVID-19 CPT codes are available from AMA website. It was carefully selected for its demonstrated promise in preclinical . 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. 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.. This site is intended for US healthcare professionals only. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. About SotrovimabSotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. Page last reviewed: 20 December 2021. Sotrovimab Vir 7831 is an investigational single-dose monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults. 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. 4; Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. limited the authorized use of the Janssen COVID-19 vaccine. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. You will then need to be monitored for around 30 minutes after the infusion is complete. website belongs to an official government organization in the United States. The Government said there was a "critical, urgent need to procure and deploy a new class of monoclonal antibodies (mAbs) that can neutralise any Covid-19 variant". [4]On April 16, 2021, the FDA revoked the EUA that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. The patient or parent/caregiver has the option to accept or refuse sotrovimab. 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. lock ) The U.S. government has paid around $530 for a 5-day course of Paxlovid, $700 per five-day course of molnupiravir, and $2,100 for a course of sotrovimab - the lone available antibody treatment. 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. Prescribing and dispensing information For sotrovimab Sotrovimab is a biological medicine. We welcome the final draft guidance from NICE which we believe is particularly meaningful as the organizations recommendations are informed by independent committees that aim to provide guidance to healthcare professionals on the best care options available to benefit their patients, said George Scangos, Ph.D., Chief Executive Officer of Vir. The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19. [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. The Government has bought a new Covid antibody treatment from GlaxoSmithKline to help patients with the virus and bolster Britain's arsenal if mutations make vaccines ineffective. what is the bench press for nba combine? 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. Sign up to get the latest information about your choice of CMS topics. Prices are for cash paying customers only and are not valid with insurance plans. [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. Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing . 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. how much does sotrovimab cost uk. The government has secured 7700 doses of sotrovimab for the national medical stockpile. 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. ICER also analyzed the cost-effectiveness of fluvoxamine, a 40-year-old generic pill used to treat conditions such as obsessive-compulsive disorder and depression at a cost of about $10 for a 10-day course. (MHRA), UK on November 4, 2021. Hospital admission or death occurred in 7 per cent of patients in the placebo group, and 1 per cent among those who received Sotrovimab. IV Compatibilities. Revised March 2022. dewitt thompson v net worth. how much does sotrovimab cost uk tuna salad with yogurt and apples. You'll only need 1 dose. Reference:Fact sheet for healthcare providers: Emergency Use Authorization (EUA) of sotrovimab. Researchers from the University of Minnesota applied in December for emergency authorization of fluvoxamine for high-risk COVID patients after studies showed that the anti-depressant, which also has anti-inflammatory properties, reduced hospitalization rates by 32%. Between Victoria, NSW and the ACT, there are 197 people in the ICU. Remove 1 vial of sotrovimab from refrigerated storage and allow to equilibrate to room temperature, protected from light, for ~15 minutes. QUICK TAKE Sotrovimab for Early Covid-19 01:56. 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(Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorisation to Xevudy (sotrovimab) for the early treatment of COVID-19.Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents . 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 . The data considered by the Therapeutic Goods Administration included 528 patients given sotrovimab and 529 given placebo. 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. [2]Given the limited clinical situations allowed under the EUA, providers should only bill for tocilizumab on a 12x type of bill (TOB). 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. Merck . 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. Mechanism: Sotrovimab is a recombinant human IgG1-kappa mAb that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 with a dissociation constant KD = 0.21 nM) but does not compete with human ACE2 receptor binding (IC50 value >33.6 nM [5 g/mL]). Its research showed that sotrovimab, the Covid-19 antibody treatment it developed with Vir . It first . Vir Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 . British National Formulary for Children (BNFC), COVID-19 in patients who do not require oxygen supplementation and are at an increased risk of severe COVID-19 infection. The three treatments - approved on an emergency basis for people with mild-to-moderate COVID-19 deemed at risk of progressing to serious illness - have been purchased by the U.S. government and are being distributed free-of-charge to healthcare providers. Next review due: 20 December 2024. There can be variation in the licensing of different medicines containing the same drug. how much does sotrovimab cost uk. The monoclonal antibody treatments are meant for mild to moderate COVID cases in adults and children over 12 to prevent the progression of severe COVID. How much VAT do I have to pay in The Netherlands? An interim analysis reported that COVID-19 had progressed in 3/291 patients infused with sotrovimab and 21/292 given a placebo. This helps eliminate the interest ra. Eligibility requirements vary for each program. 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. 1 In the United States alone, an . [9] On January 24, 2022, the FDA announced that, due to the high frequency of the Omicron variant, REGEN-COV (casirivimab and imdevimab, administered together) isnt currently authorized in any U.S region. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. Sotrovimab. ICER uses a decades-old formula called the quality-adjusted life year (QALY) the cost of one year of good health for one patient to estimate fair value. With the mass-production of recombinant mAbs now capable of meeting demand, and at a cost that is competitive with other treatments (Taylor 2021), this line of potential therapy has generated much interest amongst developers. Sotrovimab, with the brand name Xevudy, is the second. Cost Lagevrio How much lagevrio injectable for chickens.Professor Wark price Lagevrio said it wasn't practical or affordable for.Cost Of Lagevrio The recent authorization of two oral antiviral.A sotrovimab treatment in the US costs about 00.How much lagevrio injectable for chickens.For 40 Times What It Costs to Make The Covid-19 treatment molnupiravir was developed using funding from the cost . 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-19.2 1 1-3 Older patients with . Infusion-related reactions, including immediate hypersensitivity reactions, were observed in subjects treated with sotrovimab in COMET-ICE (1%) and in COMET-TAIL (<1%). Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. 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 . Who Did Louis Armstrong Influence, how much does sotrovimab cost uk. is executive career partners legitimate -&nbspbighorn mountains weather - how much does sotrovimab cost uk; 8 jun, 2022 All were Grade 1 (mild) or Grade 2 (moderate). Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen. Quality Seeds For Farmers Wealth Creation The federal . Note: This is a drug discount program, not an insurance plan. 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 COVID-19 vaccine administration are included in the Additional Resources section below. Menu. 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 . The Pfizer and Merck drugs are meant to be taken at home, while GSK's antibody is administered in hospital or infusion centers. The drug was 100 per cent successful in preventing deaths and 99 per cent effective in stopping admissions to intensive care . Sotrovimab is given one time by injection into a vein by a health care professional. [1a]Payment rate effective for dates of service on or after August 15, 2022. The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. More in Sotrovimab (Xevudy) Were the sotrovimab . If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. 1. . The industry leader for online information for tax, accounting and finance professionals. 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. GlaxoSmithKline Plc has delivered some good news amid mounting concerns about the omicron variant. The UK recorded 41,242 Covid cases on Thursday and 214 deaths within 28 days of a positive test. how much does sotrovimab cost uk. how much does sotrovimab cost uk. Serious and unexpected adverse events may occur that have not been previously reported with sotrovimab use.[Continue Reading]. 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. Important Safety Information - Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum. The government has ordered 7,700 doses of sotrovimab. It's given through a drip in your arm (infusion) over 30 minutes. The recommended dosage of Sotrovimab to treat mild-to-moderate COVID-19 infection in patients is 500 mg. People who test COVID positive should start Sotrovimab treatment immediately for. Final draft guidance based on cost effectiveness evaluation of sotrovimab. Last month, the NHS said it would start offering patients the treatment, which is a combination of two monoclonal antibodies. [5] On June 17, 2022, FDA authorized the 50MCG/0.5ML presentation of the Moderna COVID-19 Vaccine to provide primary series doses in individuals 6 years through 11 years of age in addition to the 3/29/2022 FDA authorization to provide booster vaccination doses in individuals 18 years and older. Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation. It can also be administered to pediatric patients over 12 years of age and weighing at least 40 kgs. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID19 requiring high-flow oxygen or mechanical ventilation. More than 4.8 million persons worldwide have died from coronavirus disease 2019 (Covid-19) during the global pandemic. 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 US . Some offers may be printed right from a website, others require registration, completing a questionnaire, how much does sotrovimab cost uk. Shipment of product will begin soon, and jurisdictions will see product arrive as early as Tuesday, December 21, 2021. 0. 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. Providers should only bill Medicare for commercially-purchased products. 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions. A weekly roundup of the latest news and analysis sent every Monday. Health Sotrovimab: what is Xevudy antibody treatment for Covid, does it work on Omicron, and is it approved in UK? 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. how much does sotrovimab cost uk. Sotrovimab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. 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 . Limitations of Benefit and Potential for Risk in Patients with Severe COVID19. Xevudy (sotrovimab) was approved for the following therapeutic use: Xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (see Section 5.1 .
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