Canberra (Tribune International, PM Office Release, 5 Oct 2021); Australia will have access to an additional COVID-19 treatment following the Morrison Government’s deal to purchase 300,000 courses of the promising oral COVID-19 treatment Molnupiravir.
Molnupiravir is an oral antiviral that is being developed for the first-line treatment of COVID-19 in adult patients with mild-to-moderate symptoms.
Treatment with Molnupiravir has been shown to stop people with COVID-19 developing serious symptoms, keeping them out of hospital and preventing serious illness and death.
Whilst Molnupiravir is in late stage clinical trials, the agreement between Merck Sharp & Dohme (MSD) is for supply to Australia should it be approved by the Therapeutic Good Administration (TGA), which could occur in early 2022.
Prime Minister Scott Morrison said the Government was ensuring Australians had access not only to COVID-19 vaccines, but also promising treatments.
“Vaccines and new treatments like this will boost our National Plan to safely reopen Australia and keep Australia safely open,” the Prime Minister said.
“Throughout this pandemic we’ve been closely watching developments for COVID-19 vaccines and treatments and Molnupiravir will be ready to go in Australia should it be approved by the TGA.
“While our vaccination rate continues to climb, we’ve been investing in and closely monitoring research into COVID-19 treatments and we are securing supply of promising treatments.
“If the medical experts at the TGA approve this treatment for use, it will join other COVID-19 treatments such as sotrovimab and remdesivir which are already available to Australian doctors to help treat those with COVID-19.”
Molnupiravir is a capsule that is taken twice a day for 5 days by adult patients with mild-to-moderate COVID-19 symptoms and does not need to be refrigerated, allowing it to be used in the community or as a targeted intervention at high-risk locations and in rural areas.
The makers of Molnupiravir, MSD and Ridgeback Biotherapeutics, have recently announced that Molnupiravir reduced the risk of hospitalisation or death from COVID-19 by 50 per cent at a planned interim analysis of the Phase 3 trial.
Minister for Health and Aged Care Greg Hunt added that these positive results added to the ongoing analysis the TGA has been undertaking into Molnupiravir.
“All COVID-19 treatment assessment processes are being treated with the greatest priority as part of the Government’s response to the pandemic,” Minister Hunt said.
“The TGA is allowing data on the safety and efficacy of COVID-19 treatments to be provided as it is available to allow for an early approval for use in Australia without skipping any steps.
“Vaccination remains the most important and safest way for Australians to protect themselves and their loved ones from COVID-19 – and almost 80 per cent of Australians aged 16 and over have now had their first dose.
“In addition to this, our Government will continue to seek access to further treatments which will assist with Australians living with COVID-19.”
On 9 August 2021 the TGA granted provisional determination to MSD in relation to Molnupiravir which means MSD is now eligible to apply for provisional registration for Molnupiravir in Australia. Provisional determination is the first step in the process and it is anticipated that MSD will submit a final application for provisional registration shortly.
The TGA’s consideration of Molnupiravir will occur in late 2021 and a TGA approval and delivery of the treatment to the National Medical Stockpile would occur in early 2022.
In addition to Molnupiravir, Australia has secured two dedicated COVID-19 treatments, remdesivir and sotrovimab, which are already being used to treat patients with COVID-19 across the country.