GSK welcomes government commitment to purchase the first treatment for mild-moderate COVID-19

Pharma News: Australians are set to have access to a new treatment for COVID-19, in addition to the continuously expanding the existing vaccine rollout.

GSK Australia has signed an agreement with the Australian Government to purchase its new COVID-19 treatment, once approved by the Therapeutic Goods Administration’s (TGA).

The TGA previously granted GSK’s sotrovimab a provisional determination in April 2021, which provides a mechanism for accelerating the provisional registration of promising new medicines. If it receives provisional approval from the TGA, it will be the first treatment to receive regulatory approval to treat early stage COVID-19 in Australia.

The Australian Government’s agreement with GSK includes delivery of more than 7,700 doses for the National Medical Stockpile, with an initial delivery this year upon TGA approval.

The advanced purchase of sotrovimab has been supported by the Science and Industry Technical Advisory Group (SITAG), which is the Australian Government’s expert group advising on COVID-19 vaccine and treatment purchases.

Dr Krystal Evans, Medical Lead for COVID Therapeutics at GSK Australia, said that the company is pleased to be part of ensuring the Australian community are able to have an early treatment option against COVID-19.

“GSK is committed to partnering with the Australian Government to ensure Australians get prompt access to emerging treatments once they have been approved by the appropriate regulators,” Dr Evans commented.

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.

Sotrovimab will be the first COVID-19 monoclonal antibody treatment available for use in this country, with the complete treatment requiring just one dose administered via IV infusion in a healthcare facility.

Where a doctor prescribes this treatment for their patients with mild to moderate COVID-19, who are at risk of developing severe COVID-19, it will be made available free of charge through the public health system.

Clinician estimates of the Australian patient treatment population range from 8-15% of patients who are SARS-CoV2 positive that would be considered at high risk of disease progression and would be recommended for treatment with sotrovimab, based on past and current experience of managing COVID-19 patients.