TGA evaluating first monoclonal antibody treatment for COVID-19, SOTROVIMAB - GlaxoSmithKline Australia Pty Ltd

The Therapeutic Goods Administration (TGA), part of the Department of Health, granted a provisional determination to GlaxoSmithKline Australia Pty Ltd (GSK) in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14th April 2021. The TGA has now received GSK's application for provisional registration and is evaluating the preliminary data for SOTROVIMAB.

All COVID-19 medicine applications are being treated with the greatest priority as part of the Department of Health's response to the pandemic. Under normal circumstances, TGA's assessment (for both provisional and general registration) begins once all information to support registration is available. For COVID-19 treatments, the TGA has agreed to accept rolling data to enable early evaluation of data as it comes to hand.

What is a rolling review?

To register a COVID-19 medicine in Australia, a sponsor is required to submit a comprehensive dossier that includes specific information on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.

Many of the large-scale clinical trials that will provide evidence of safety and effectiveness are still progressing and these results will be provided to the TGA as they become available. This allows for early evaluation of data.

How the medicine is expected to work?

Antibodies are proteins that are produced by our own body's immune system and are one of the main ways the body defends itself against diseases. Antibodies work by binding to a specific target - for example a virus or a bacteria - and making them harmless. They block or slow down the action of the virus or bacteria, or they flag it as 'foreign' so that other parts of our immune system can clear the 'invaders' away. Monoclonal antibodies work in the same way.

Monoclonal antibodies are laboratory-made proteins that mimic our body's immune system to help fight off harmful pathogens.

Monoclonal antibodies can also help to 'turn down' an immune response when the body is over reacting, which is what can happen with some COVID-19 patients. That is, monoclonal antibodies may help to treat people who already have COVID-19.

Monoclonal antibodies have been safely and effectively used to treat a growing number of diseases, some of which were difficult to treat in the past.

Further information

Further information on COVID-19 treatments, including monoclonal antibodies, will be published on the TGA's website in due course.