Sotrovimab has been approved for patients with mild-to-moderate COVID-19 who are at high risk of developing severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the monoclonal antibody treatment Sotrovimab (Xevudy; GSK and Vir Biotechnology) for people with mild-to-moderate COVID-19 and at least one risk factor for developing severe illness.

Sotrovimab is the second monoclonal antibody treatment approved by the MHRA and sotrovimab is a monotherapy.

“Sotrovimab also has been authorized by the U.S. FDA for the emergency use.”

In a statement on the 12 November 2021, GSK said clinical trial results showed that a single dose of sotrovimab reduced the risk of hospitalisation and death by 79% in COVID-19 patients with risk factors, such as obesity or diabetes, compared with the placebo group. The full trial results have not been made public or peer reviewed.

These data also indicated that sotrovimab was most effective when taken during the early stages of infection; therefore the MHRA has recommended that it is used within 5 days of symptom onset.

Monoclonal antibody treatments work by binding to the spike protein on the outside of the COVID-19 virus, which prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.

Dosage
The dosage 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) is 500 mg of sotrovimab.

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 IV infusion over 30 minutes.

Source:

The Pharmaceutical Journal, PJ, December 2021, Vol 307, No 7956;307(7956)::DOI:10.1211/PJ.2021.1.118809  

https://pharmaceutical-journal.com/article/news/second-monoclonal-antibody-treatment-for-covid-19-approved-in-the-uk?fbclid=IwAR3Ge-N-sBryv-c9Smj8ZwWyncOaljUDWEM2TSldICDtez3xgyYL-HxYd6k

https://www.fda.gov/media/149534/download

https://www.gov.uk/government/news/mhra-approves-xevudy-sotrovimab-a-covid-19-treatment-found-to-cut-hospitalisation-and-death-by-79

https://www.gsk.com/en-gb/media/press-releases/preclinical-data-demonstrate-sotrovimab-retains-activity-against-key-omicron-mutations-new-sars-cov-2-variant/#

Note: For informational purposes only. Consult your textbook for advising your patients.