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TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment - SOTROVIMAB

14 April 2021

The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination to GlaxoSmithKline Australia Pty Ltd (GSK) in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136).

The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG).

Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the treatment will be provisionally approved for inclusion in the ARTG.

The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data. In order to apply for provisional registration, the sponsor must first apply for a provisional determination. Further information on eligibility criteria can be found at Provisional registration process.

In making its decision to grant GSK a provisional determination, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.

The TGA continues to work with sponsors to prioritise all queries and applications for COVID-19 treatments and vaccines.

What are monoclonal antibodies?

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.

The TGA will publish further information on monoclonal antibodies and other COVID-19 treatments in the coming days, in the meantime, further information can be found at: https://www.gavi.org/vaccineswork/what-are-monoclonal-antibodies-and-can-they-treat-covid-19.