花费10亿美元！美国政府出资购买COVID-19治疗药物sotrovimab

On November 17, 2021, GlaxoSmithKline and Vir Biotechnology announced that the U.S. government had reached an agreement with them to spend approximately US$1 billion to purchase sotrovimab. Sotrovimab is an investigational monoclonal antibody for the early treatment of COVID-19, for which the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) in May 2021. GlaxoSmithKline will make the drug available to the U.S. government by December 17, 2021, making sotrovimab available to patients nationwide.

In addition to the doses that will be delivered this year, the U.S. government can purchase additional doses through March 2022.

Sotrovimab is an investigational single-dose intravenous SARS-CoV-2 monoclonal antibody authorized by the FDA EUA. Under the EUA, sotrovimab can be used to treat adult and pediatric patients (12 years and older and at least 40 kg) with mild to moderate COVID-19 who test positive for COVID-19, as well as patients who are at high risk of progression to severe disease, including hospitalization or death.

Hal Barron, Ph.D., chief scientific officer and president of research and development at GlaxoSmithKline, said: "Given the large number of patients who continue to be infected with COVID-19 in many parts of the United States, there is a need for more effective treatments. We are proud to work with the U.S. government to help these patients obtain sotrovimab."

George Scangos, Ph.D., CEO of Vir Biotechnology, said: "Monoclonal antibodies play an important role in treating patients with COVID-19, and we are pleased that this agreement will make sotrovimab available to more healthcare providers and patients who are at high risk of developing severe disease. With evidence demonstrating the ability of sotrovimab to maintain activity against detected circulating variant strains, including Delta, we believe sotrovimab will continue to play an important role in the fight against COVID-19."

In June 2021, GlaxoSmithKline and Vir Biotechnology announced the conclusive full results of the Phase 3 COMET-ICE trial. Compared with placebo, sotrovimab reduced the number of patients who were hospitalized for more than 24 hours or died from all causes by 79% (adjusted relative risk reduction) within 29 days, reaching the trial's primary endpoint.

The companies also recently announced topline data from the randomized, multicenter, open-label Phase 3 COMET-TAIL trial, which met its primary endpoint, demonstrating that sotrovimab was non-inferior to intravenous administration for the early treatment of high-risk, non-hospitalized adult and pediatric patients (12 years and older) with mild to moderate COVID-19. The companies plan to advance regulatory submissions globally.

References:

https://us.gsk.com/en-us/media/press-releases/gsk-and-vir-biotechnology-announce-united-states-government-agreements-to-purchase-sotrovimab-a-covid-19-treatment/