First treatment for mild-moderate COVID-19 now TGA approved

Pharma News: GSK Australia and Vir Biotechnology welcome the Therapeutic Goods Administration (TGA) provisional approval of Xevudy (sotrovimab), a monoclonal antibody and the first treatment for mild-moderate COVID-19.

Dr Krystal Evans, Medical Lead for COVID Therapeutics at GSK Australia, said the provisional approval is an important milestone in the strategy to combat COVID-19 in Australia.

“Sotrovimab is the first monoclonal antibody treatment approved for COVID-19 in Australia. We think this new treatment option could play a role in our longer-term management of COVID-19 as part of Australia’s pandemic response toolkit,” said Dr Evans.

“If we can treat people at the time of diagnosis, then we may be able to prevent the disease from getting more serious and help keep people out of hospital. 

“Vaccines are a critical element in our response to the pandemic and we also need to have a range of interventions available if people do become infected, to keep people out of hospital and reduce the severity of the disease. This means social distancing, hand washing, mask-wearing, vaccination and effective evidenced-based treatment options.” 

Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalisation or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial. In vitro data indicates sotrovimab maintains activity against all known variants of concern.

Despite this evidence and the international approval of this drug, Australia’s National COVID-19 Clinical Evidence Taskforce recommends ‘Do not use sotrovimab for the treatment of COVID-19 outside of randomised trials with appropriate ethical approval.’

Associate Professor Paul Griffin, practicing infectious diseases physician and clinical microbiologist, said he welcomed the approval of an early treatment for COVID-19 in Australia.

“Having evidence-based medicines to provide early treatment for those most vulnerable to the virus is an important pillar in managing the pandemic,” said A/Prof Griffin. 

George Scangos, Ph.D., chief executive officer of Vir, said “The provisional approval of sotrovimab in Australia marks an important milestone for Vir, as it is the first marketing authorisation of our first commercial product. It also represents an important step forward in the Australian Government’s efforts to combat the pandemic and prevent the most severe effects of COVID-19, particularly in the face of new and emerging variants. We eagerly anticipate additional regulatory decisions around the world in the coming months and look forward to working with our partner, GSK, to expand patient access to a much-needed treatment option that continues to demonstrate, in vitro, its ability to retain activity against the tested, currently circulating variants of concern and interest, including Delta and Delta Plus.”

“New treatment options have the potential to keep people out of hospital, prevent their disease from progressing and reduce the burden on the health system. These outcomes are a key objective in our management of COVID-19 in the community and new treatments will help us get there.” 
Dr Evans said GSK Australia was proud to help bring this innovation to patients. 

“The announcement is welcome news for patients and the Australian community. It follows extensive work right around the world in collaboration with our partners at Vir Biotechnology,” concluded Dr Evans. 

Sotrovimab’s treatment requires just one dose administered via IV infusion in a healthcare facility.