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Eli Lilly puts antibody therapy on hold over safety concerns Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. The data supporting this EUA for bamlanivimab are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Of these patients, 101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS- CoV-2 viral test. The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo. Most patients, including those receiving placebo, cleared the virus by day 11. However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID- 19-related hospitalizations or emergency room visits within 28 days after treatment. FDA OKAYS CASIRIVIMAB- IMDEVIMAB COMBO FOR TREATING COVID-19 The US FDA issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older weighing at least 40 kilograms) and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Casirivimab and imdevimab must be administered together by intravenous (IV) infusion. The drugs are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Benefits of casirivimab and imdevimab treatment have not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation, according to an FDA statement. The data supporting this EUA for casirivimab and imdevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 799 non-hospitalized adults with mild to moderate COVID-19 symptoms. Of these patients, 266 received a single intravenous infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo, within three days of obtaining a positive SARS-CoV-2 viral test. The prespecified primary endpoint for the trial was time-weighted average change in viral load from baseline. Viral load reduction in patients treated with casirivimab and imdevimab was larger than in patients treated with placebo at day seven. However, the most important evidence that casirivimab and imdevimab administered together may be effective came from the predefined secondary endpoint of medically attended visits related to COVID-19, particularly hospitalizations and emergency room visits within 28 days after treatment. For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated patients on average compared to 9% in placebo-treated patients. The effects on viral load, reduction in hospitalizations and ER visits were similar in patients receiving either of the two casirivimab and imdevimab doses, Regeneron Pharmaceuticals said. 20 / FUTURE MEDICINE / December 2020
CureVac, EU ink supply deal for mRNA vaccine CureVac, a German biotech firm, has agreed to supply the EU with 225 million COVID-19 vaccine doses initially, with an option for another 180 million doses, reports said. The CureVac deal targets to supply nearly 2 billion doses to the bloc. The EU already had COVID-19 vaccine supply agreements with AstraZeneca, Johnson & Johnson, Sanofi and Pfizer. CureVac announced the advancement of its programme into phase 2a testing in Peru and Panama back in September. The company recently unveiled some promising early data. and touted the candidate’s stability after Pfizer posted impressive early efficacy figures for its mRNA shot. While Pfizer’s vaccine requires storage at -94 degrees Fahrenheit and will only last for 24 hours at refrigerated temperatures, CureVac says its candidate is stable for at least three months at refrigerated temperatures and up to 24 hours at room temperature. Baricitinib in combo with remdesivir to treat hospitalized patients Eli Lilly and Incyte announced that the US FDA issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and paediatric patients two years of age or older with suspected or laboratoryconfirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). All patients received standard supportive care by the trial site hospital. The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge. Patients treated with baricitinib in combination with remdesivir had a significant reduction in median time to recovery from 8 to 7 days (12.5% improvement) compared to remdesivir. December 2020 / FUTURE MEDICINE / 21
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