TGA approves two new Covid-19 medications amid Omicron case surge

Australians will soon be able to access the first oral Covid-19 medications after a major breakthrough overnight.

Covid-positive Australians who are at risk of serious illness will soon have access to two breakthrough treatments in an attempt to keep them out of intensive care and reduce deaths.

The Therapeutic Goods Administration has granted provisional approval to two products – Pfizer’s Paxlovid (nirmatrelvir and ritonavir) and Lagevrio (molnupiravir) produced by Merck Sharp & Dohme.

The oral medications are the first to be approved for Covid-19 in Australia, and will be used in adults who are at “increased risk of progression to hospitalisation or death”.

TGA head professor John Skerritt said the medicines will be targeted in aged care facilities and at older Australians, and that neither product are intended to be used as a substitute for Covid-19 vaccination.

Health Minister Greg Hunt said the products were expected to arrive in coming weeks, after the government secured 500,000 courses of Paxlovid and 300,000 courses of Lagevrio.

Health Minister Greg Hunt said the courses of antiviral medication will begin arriving in Australia in the coming weeks. Picture: NCA NewsWire/ David Crosling

“They will help people who are at increase risk of going from mild to moderate and deemed by medical professionals to have the risk of progression of more serious conditions,” Mr Hunt said.

“They are expected to arrive in the coming weeks.

“They will build on what we’re already doing through the intravenous or hospital treatments.”

The TGA said either medicine should be administered “as soon as possible” after a Covid-19 diagnosis, and within five days of symptom onset.

Both medicines require a prescription, and are taken twice a day for five days.

Professor Skerritt said there was no indication that one was better than the other.

“It’s common, it’s an ideal situation in medicine - whether you’re treating cancer or a virus, or common things like diabetes - to have a selection of medicines,” he said.

“Because there will be times when one is indicated for certain groups of patients and one for another group of patients.

“Both medicines in the clinical trials were very effective in reducing death.

“That of course is the most important thing, especially as these medicines will be rolled out especially in aged care... While we are sadly seeing some younger deaths, it’s still largely the older people if you look at the proportion of people who are dying, even in the last month or so.”

A transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Picture: AFP

The drugs work differently, but both target the virus and keep it from further spreading.

“Lagevrio works by inhibiting replication of the SARS-CoV-2 virus,” a TGA statement said.

“Regarding Paxlovid, the nirmatrelvir component blocks the activity of a protease enzyme that the coronavirus needs in order to replicate. Nirmatrelvir is administered in combination with low-dose ritonavir to maintain plasma levels of nirmatrelvir for the duration of the treatment.”

The two new medicines will supplement the existing stockpile made up of Sotovimab – used in people with mild to moderate Covid-19 at risk of severe disease, and Remdesivir – used in people with moderate to severe Covid-19.

Mr Hunt said not everyone who contracts Covid-19 would need medication.

“These treatments (Lagevrio and Paxlovid) will be of most benefit for people most at risk of severe disease,” he said.

“We are working to target access to the most vulnerable including the elderly and those in aged care.

“Whilst vaccination remains the best protection against Covid-19, our government continues work to ensure Australians have early access to safe and effective treatments as they are approved for use by the medical experts.

“As with all Covid-19 treatments, both of these medications have been rigorously assessed by the TGA for safety, quality and effectiveness.”

Pfizer’s Covid-19 antiviral pills, Paxlovid, will be used in adults at high risk of progressing to serious disease. (Picture: Pfizer / AFP)

The TGA has warned that the treatments cannot be used by everyone, with Lagevrio not recommended for women who are pregnant or breastfeeding.

Sexually active women of child-bearing age should use contraception for three months after taking the treatment.

The same recommendations apply to Paxlovid.

Paxlovid must also not be used with a number of commonly used medicines, the TGA said.

The combination may lead to harmful increases in blood levels or reduce the activity of the Covid treatment.