TGA gives early approval to first oral treatments for COVID in Australia

By Jackson Graham

January 20, 2022

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The medicine is for adults with the virus who do not need oxygen. (doucefleur/Adobe)

The first oral treatments for at-risk adults with COVID-19 have received early approval for use in Australia, the medical regulator says. 

The Therapeutic Goods Administration announced on Thursday it had provisionally approved a tablet made by Pfizer called Paxlovid, and capsules made by Merck Sharp & Dohme called Lagevrio for treating coronavirus. 

Australia is expecting 500,000 treatment courses of Paxlovid and 300,000 courses of Lageviro to arrive this year, with the first shipments due in coming weeks.  

The medicine is for adults with the virus who do not need oxygen but are at increased risk of progressing to hospital or dying. 

Both drugs are taken twice a day for five days as soon as possible after diagnosis and within five days of symptoms starting. 

“Neither product is intended to be used as a substitute for vaccination against COVID-19,” the TGA said in a statement. 

Lagevrio inhibits replication of the virus, while Paxlovid blocks the activity of a protease enzyme that the coronavirus needs in order to replicate. 

Neither medicine is recommended for women who are in pregnancy or breastfeeding. 

Sexually active women are recommended to use contraception with both drugs, and sexually active men and women taking Lageviro are to use contraception for three months after treatment. 

A number of other medicines are also not recommended to be used with Paxlovid because they can lead to harmful increases in blood levels or reduce the effect of the treatment. 

The TGA says the drug is not to be used on patients with severely reduced kidney or liver function. 

The TGA relied on advice from the independent Advisory Committee on Medicines in making the provisional approval. 

“Australians can be confident that the TGA’s review process of both medicines was rigorous,” it said.


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