TGA nod bolsters new Covid drug hopes

Australia’s stockpile of coronavirus treatments is set to receive a further boost after the country’s drug regulator granted provisional approval to two breakthrough treatments.

TGA grants provisional approval to breakthrough antiviral drugs. Picture: Getty Images

Australia’s stockpile of coronavirus treatments is set to receive a further boost after the country’s drug regulator granted provisional approval to two breakthrough treatments aiming to keep Covid-positive patients out of ­intensive care.

Therapeutic Goods Administration head John Skerritt announced on Thursday the regulator had granted provisional approval to the country’s first oral treatments, Paxlovid and Legevrio.

The two antivirals have been championed as breakthrough treatments in the UK and US since the end of last year, with ­clinicians using them to prevent Covid-positive patients from progressing to serious illness and hospitalisation.

In December, Pfizer revealed that clinical trials of its drug ­Paxlovid had showed the pill could withstand the Omicron variant and drastically reduce hospitalisation and death rates among at-risk people by almost 90 per cent.

The antiviral is a combination of two drugs, Nirmatrelvir and Ritonavir, which can both be taken orally over five days.

It is regarded as more variant-proof than other treatments, such as synthetic antibody ­infusions.

The antiviral treatment ­Legevrio, manufactured by pharmaceutical giant Merck, has also been well received as an ­effective “at-home treatment” for Covid-19 patients.

Professor Skerritt told reporters the treatments would first be used to target aged-care facilities, emphasising that neither drug should be used as a substitute for vaccination.

He also emphasised that there was no indication that one drug was superior to the other, saying it was an ideal situation “to have a selection of medicines” to treat the virus.

“There will be times when one drug is indicated for certain groups of patients and one for another group of patients,” he said.

Professor Skerritt added that both medicines had been shown to be equally effective in ­reducing death during their clinical trials.

The TGA said the medicines should be administered to a ­patient “as soon as possible” after a Covid-19 diagnosis and within five days of the onset of ­symptoms.

At Thursday’s press conference, Health Minister Greg Hunt said the products were expected to arrive in the coming weeks, after the government secured 500,000 courses of Paxlovid and 300,000 courses of Legevrio.

While both drugs have ­received provisional approval, the manufacturers will be required to submit further data to the TGA as the drugs are used more widely.

The TGA said the two ­medicines would supplement the existing stockpile made up of the monoclonal treatment ­Sotrovimab, administered to people with mild-to-moderate Covid-19, and the antiviral drug Remdesivir, used in people with moderate-to-severe Covid-19.

Since last June, the TGA has approved and purchased more than 60,000 courses of ­Remdesivir and the monoclonal treatment Sotrovimab in a bid to broaden its armoury of Covid-19 treatments.

The government has also ­ordered 15,000 courses of the antibody-based therapy Ronapreve and 500,000 of Pfizer’s ­antiviral drug PF-07321332, while it continues to evaluate Roche’s treatment Tocilizumab.