First monoclonal antibody treatment approved for COVID-19 in Australia

GSK Australia and Vir Biotechnology have today welcomed the Therapeutic Goods Administration (TGA) provisional approval of sotrovimab, a monoclonal antibody (under the product name Xevudy), for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death¹.

The design of monoclonal antibodies is based on the natural antibodies humans already make. The role of monoclonal antibodies is to bind to the virus, stop it entering host cells and help fight off already infected cells¹.

Dr Krystal Evans, Medical Lead for COVID Therapeutics at GSK Australia, says 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.”

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.

“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.

“Today’s 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.

The TGA had previously granted sotrovimab a provisional determination in April, which provides a mechanism for accelerating the provisional registration of promising new medicines. The provisional approval pathway allows companies to apply for time-limited registration for a promising treatment for a serious or life-threatening condition.