TGA provisionally approves two Covid treatments

While vaccinations remain the best protection against Covid-19, the Australian Government welcomes the Therapeutic Goods Administration’s (TGA) provisional approval for the first oral treatments for Covid-19 – Lagevrio and Paxlovid.

Lagevrio and Paxlovid are oral anti-viral treatments that have reportedly been found to be effective in treating people with mild-to-moderate Covid-19 who have a high risk of progressing to severe disease, reducing admissions to hospital and ICU and potential death.

These oral antiviral treatments need a prescription and are taken every 12 hours for five days. They are designed to interfere with the virus’s ability to multiply.

The clinical trials of these treatments show they reduce the risk of hospitalisation or death in patients with Covid-19 who are at high risk of progressing to severe disease.

The Government has reportedly secured access to 300,000 treatment courses of Merck Sharp & Dohme’s (MSD) Lagevrio and 500,000 courses of Pfizer’s Paxlovid for supply throughout the course of 2022.

The first deliveries of both medicines are anticipated over the coming weeks.

Dr Gary Jankelowitz, Medical Director, MSD Australia says, “The provisional approval of this oral antiviral treatment for Covid-19 in eligible at-risk adults is a regulatory milestone in the ongoing fight against Covid-19.

“Lagevrio has the potential to help address a medical need in the community. MSD acknowledges the partnership and support of the Australian Government and the Minister for Health and Aged Care, Hon Greg Hunt MP, in making this treatment option available for eligible adults.”

Dr Paul Griffin, Infectious Disease Physician and Microbiologist at Mater Health, Brisbane, says “Taken twice daily for five days, access to this oral antiviral [Lagevrio] provides an additional option to Australia’s pandemic response.

“Importantly, this treatment allows the virus to be treated in community settings.

“The availability of an oral treatment for eligible patients with mild-to-moderate disease will mean that patients will be able to be at home and be actively treated.

“Vaccination is still the number one line of defence against Covid-19, but we need multiple defences against the virus, including treatments for those who are at high risk for progression to severe disease,” continues Dr Griffin.

Pfizer Australia and New Zealand Managing Director, Anne Harris says,  “This milestone in Australia is an important moment in our continued fight against Covid-19, paving the way for use of Paxlovid as cases continue to rise and we address the threat of a new variant of concern, Omicron.

“This at-oral therapy, developed to reduce hospitalisations and save lives, has the potential to transform Covid-19 treatment and help lessen the devastating impact of the virus that has now taken over 5 million lives globally”, she adds.

As with other TGA approved Covid-19 treatments not everyone who contracts Covid will require access to Lagevrio and Paxlovid, and these treatments will be of most benefit for people most at risk of severe disease and through the oversight from a healthcare professional.

Like with all Covid-19 treatments, both of these medications have been rigorously assessed by the TGA for safety, quality and effectiveness before being provisionally registered for use in Australia.

The TGA is treating all Covid-19 treatment applications with the greatest priority as part of the Department of Health’s response to the pandemic.

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