On 16 December 2021, the CHMP recommended authorizing sotrovimab for use in the EU and authorization was granted the next day.In May 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sotrovimab for the treatment of mild-to-moderate COVID-19 in people aged aged twelve years and above weighing at least 40 kilograms (88 lb) 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.In August 2021, sotrovimab was granted provisional approval for the treatment of COVID-19 in Australia.In September 2021, sotrovimab was granted special exception authorization in Japan.In December 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom approved sotrovimab for use in people aged twelve years of age and over who weigh more than 40 kilograms (88 lb).In March 2022, the FDA withdrew the EUA for sotrovimab in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico, the Virgin Islands, Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin, Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, Republic of Palau, Alaska, Idaho, Oregon, and Washington due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant. In April 2022, the FDA withdrew the EUA for sotrovimab.
Research
Sotrovimab is being evaluated in the following clinical trials:
Clinical trial number NCT04545060 for "COMET-ICE" at ClinicalTrials.gov
Clinical trial number NCT04779879 for "COMET-PEAK" at ClinicalTrials.gov
Clinical trial number NCT04501978 for "ACTIV-3-TICO" at ClinicalTrials.gov
Clinical trial number NCT04634409 for "BLAZE-4" at ClinicalTrials.govIn March 2022, Australian virologists observed that sotrovimab may cause a drug-resistant mutation. References
External links
"Sotrovimab". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT04545060 for "VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE)" at ClinicalTrials.gov
Australian Public Assessment Report: Sotrovimab. Therapeutic Goods Administration (TGA) (Report). 20 August 2021.