The company that makes the antiviral drug called Molnupiravir says it will soon submit an application to the TGA seeking provisional approval for the medicine.
The drug is currently the subject of a phase 3 trial involving more than 1800 patients around the world.
The pill is taken twice a day and is designed to prevent the virus from replicating in the body in the early days of diagnosis.
“Merck has just completed a phase 2 trial which is about efficacy and at the two highest doses they studied, so patients taking two capsules a day, they found that after just five days of treatment patients had zero copies of the virus that were detectable in their body,” said Associate Professor Nial Wheate, School of Pharmacy at the University of Sydney.
In June, the US government ordered 1.7 million courses of the drug pending their medical watchdog the FDA, authorising the medicines use.
US authorities said the drug is being evaluated to reduce the risk of hospitalisation or death in patients who have symptoms for up to five days and are at high risk for severe disease.
“Antivirals can and are an important compliment to existing vaccines especially for individuals with certain conditions that might put them at a greater risk for those whom vaccines may not be as protective,” Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said.
So far, many of the promising drugs to fight COVID019 are aimed at helping patients in a hospital setting.
This week the Australian government secured 7700 doses of a monoclonal antibody called sotrovimab which requires a one dose intravenous infusion at a healthcare facility.
The treatment, which is currently being assessed by the TGA, can dramatically reduce a person’s risk of going into hospital or dying if they have mild to moderate COVID-19.
The antiviral pill on the other hand, which was initially developed for influenza, is a direct-acting small molecule therapy.
“This is the first drug that we’ve got that could be dispensed from a pharmacy and taken at home for people who only have mild or moderate symptoms of the virus,” Associate Professor Nial Wheate said.
In a statement the drug’s maker MSD Australia said it has “had productive discussions with the Australian Department of Health about Molnupiravir, and is committed to working with the Australian Government in making this treatment option rapidly available should it receive approval by the TGA.”