- 2 years ago
20 January 2022
The TGA has provisionally approved two antiviral pills that can be taken at home to prevent people with Covid from being hospitalised and reducing their risk of death, with the first deliveries of both medicines anticipated in the coming weeks.
MSD’s antiviral pill LAGEVRIO (molnupiravir) and Pfizer’s PAXLOVID (nirmatrelvir/ritonavir) became the first oral antiviral treatments provisionally approved in Australia today (Thursday) for adult patients at increased risk of being hospitalised or dying from the virus.
The Federal Government has already secured 300,000 treatment courses of Lagevrio and 500,000 doses of Paxlovid under advance purchase deals inked last October. The antiviral pills will be added to the National Medical Stockpile and can be prescribed by GPs for prescribing to Australians who contract the virus and whose condition does not seem to be improving.
Health Minister Greg Hunt said the antivirals will be targeted “at those who are most at risk of moving from mild illness, or moderate illness, to serious illness so, in particular, the elderly or the frail”.
“Constant research has helped to deliver the vaccines and the treatments, and these two new treatments will add to the things that are already happening in our hospitals, which has meant we’ve got one of the lowest losses of life in the world,” Minister Hunt said.
MSD Australian Medical Director Dr Gary Jankelowitz said the provisional approval of Lagevrio was “a regulatory milestone in the ongoing fight against COVID-19” and “has the potential to help address a medical need in the community”.
Both Lagevrio and Paxlovid should be administered as soon as possible after a diagnosis has been made and within five days of symptom onset.
“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,” Pfizer ANZ Managing Director Anne Harris said.
“This 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 one million lives globally.”
Brisbane’s Mater Health Infectious Disease expert Dr Paul Griffin said access to 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,” Dr Griffin said.
“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.”
Both antivirals have received conditional marketing authorisation in the UK and emergency use authorisation in the US, with Paxlovid authorised by Health Canada earlier this week. Australia has now provisionally approved five Covid treatments and four Covid vaccines.