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Emergency Use Authorization (EUA) for Sotrovimab 500 Mg Center for Drug Evaluation and Research (CDER) Review

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Emergency Use Authorization (EUA) for Sotrovimab 500 Mg Center for Drug Evaluation and Research (CDER) Review Emergency Use Authorization (EUA) for Sotrovimab 500 mg Center for Drug Evaluation and Research (CDER) Review Identifying Information Application Type EUA (EUA or Pre-EUA) If EUA, designate whether pre-event or intra-event EUA request. EUA Application EUA 000100 Number(s) Sponsor (entity EUA Sponsor requesting EUA or GlaxoSmithKline Research & Development Limited pre-EUA 980 Great West Road consideration), point Brentford Middlesex, TW8 9GS of contact, address, UK phone number, fax number, email GSK US Point of Contact address Debra H. Lake, M.S. Sr. Director Global Regulatory Affairs GlaxoSmithKline 5 Moore Drive PO Box 13398 Research Triangle Park, NC 27709-3398 (b) (6) Email: Phone Manufacturer, if GlaxoSmithKline, Parma. different from Sponsor Submission Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 Receipt Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 OND Division / Office Division of Antivirals /Office of Infectious Disease 1 Reference ID: 4802027 Product in the No Strategic National Stockpile (SNS) Distributor, if other (b) (4) than Sponsor I. EUA Determination/Declaration On February 4, 2020, the Secretary of Health and Human Services determined pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States (US) citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, the Secretary of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. II. Recommendations A. Recommend EUA Issuance The Division of Antivirals, Office of Infectious Diseases, Office of New Drugs, CDER recommends EUA issuance. The EUA will authorize sotrovimab 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. B. Eligibility of the Product for an EUA COVID-19 is a serious or life-threatening disease or condition caused by SARS-CoV-2, as specified in the declaration of emergency. Based on the totality of the scientific evidence available to FDA, including data from adequate and well-controlled trials, it is reasonable to believe that sotrovimab monotherapy may be effective 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; and when used under such conditions, the 3 Reference ID: 4802027 known and potential benefits of sotrovimab monotherapy outweigh the known and potential risks of the product. There is no adequate, approved, and available alternative to 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. Sotrovimab is a recombinant human IgG1κ monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 but does not compete with human ACE2 receptor binding. Remdesivir (Veklury®) is the only drug approved by FDA to treat COVID-19 at the time of FDA’s review of sotrovimab. Remdesivir is a nucleotide analog RNA polymerase inhibitor that has demonstrated antiviral activity against SARS-CoV-2. Remdesivir’s approved indication is limited to the treatment of COVID-19 in adults and pediatric patients (12 years of age and weighing at least 40 kg) requiring hospitalization. III. Proposed Use and Dosing of the Product Under the EUA Proposed Use under EUA Sotrovimab is authorized for use under an Emergency Use Authorization (EUA) 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. The following medical conditions or other factors may place adults and pediatric patients (12 to 17 years of age weighing at least 40 kg) at higher risk for progression to severe COVID-19: Older age (for example, ≥65 years of age) SEE ATTACHED ADDENDUM Obesity or being overweight (for example, adults with BMI > , or if 12 to 17, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical charts.htm) Pregnancy Chronic kidney disease Diabetes Immunosuppressive disease or immunosuppressive treatment Cardiovascular disease (including congenital heart disease) or hypertension Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension) Sickle cell disease 4 Reference ID: 4802027 Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies) Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]) Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra- precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient. LIMITATIONS OF AUTHORIZED USE Sotrovimab is not authorized for use in patients: o who are hospitalized due to COVID-19, OR o who require oxygen therapy due to COVID-19, OR o who require an increase in baseline oxygen flow rate due to COVID- 19 (in those on chronic oxygen therapy due to underlying non- COVID-19 related comorbidity). Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Authorized Dosage under EUA Adults and Pediatric Patients The dosage of sotrovimab in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is a single IV infusion of 500 mg. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. Sotrovimab must be diluted and administered as a single intravenous infusion over 30 minutes. Sotrovimab is not authorized for patients under 12 years of age or pediatric patients weighing less than 40 kg. Pregnant or Lactating Patients 5 Reference ID: 4802027 No dosage adjustment is recommended in pregnant or lactating women. Sotrovimab has not been studied in pregnant or lactating women. Sotrovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Other Specific Populations (e.g., geriatric patients, patients with renal or hepatic impairment) No dosage adjustment is recommended in geriatric patients. Clinical trials of sotrovimab have included patients over 65, including those over 70 years of age, but the difference in pharmacokinetics (PK) of sotrovimab in geriatric patients compared to younger patients has not been quantified. No dosage adjustment is recommended in patients with renal impairment. No clinical trials have been conducted to evaluate the effects of renal impairment on the PK of sotrovimab. Sotrovimab is not eliminated intact in the urine, thus renal impairment is not expected to affect the exposure of sotrovimab. No clinical trials have been conducted to evaluate the effects of hepatic impairment on the PK of sotrovimab. The impact of hepatic impairment on the PK of sotrovimab is unknown. The effect of other covariates (e.g., sex, race, body weight, disease severity) on PK of sotrovimab is unknown. Rationale for Dose Sotrovimab 500 mg is the sole dose evaluated to date in clinical trials, including the pivotal trial, VIR-7831-5001 (COMET-ICE), that supports this EUA. Although sotrovimab was administered as an IV infusion over 60 minutes in COMET-ICE, a faster infusion time of 30 minutes is supported by safety data from the trial J2X- MC-PYAH (BLAZE-4, Arms 7 and 8). Therefore, the authorized dosage and administration is sotrovimab 500 mg administered as an IV infusion over 30 minutes. Please refer to Section XI Human Clinical Pharmacology for data to support the sotrovimab 500 mg dose against SARS-CoV-2 variants and Section XIII Nonclinical Data to Support Efficacy for data to support sotrovimab activity against SARS-CoV-2 variants. IV. Product Information (Dose Preparation and Administration) Preparation Sotrovimab is supplied in a single-dose vial and must be diluted prior to administration. 6 Reference ID: 4802027 Sotrovimab injection should be prepared by a qualified healthcare professional using aseptic technique.
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