The Hon Greg Hunt MP
Minister for Health and Aged Care
The Australian Government has secured access to two additional COVID-19 treatments to support the ³Ô¹ÏÍøÕ¾ Plan to Transition Australia’s COVID-19 response, following expert medical advice.
Under a new management with Roche Products Pty Ltd, Australia will be supplied with 15,000 doses of the COVID-19 antibody-based therapy, Ronapreve.
First supply of this treatment is expected to be available by the end of this month through an initial shipment of 5,000 doses and will be held in the ³Ô¹ÏÍøÕ¾ Medical Stockpile.
Use of this treatment will occur in line with the regulatory approval by Australia’s Therapeutic Goods Administration (TGA) and advice from the ³Ô¹ÏÍøÕ¾ COVID-19 Clinical Evidence Taskforce.
Ronapreve is a combination of two monoclonal antibodies – casirivimab and imdevimab. It is designed to block infectivity of the SARS-CoV-2 virus, which causes COVID-19. The two monoclonal antibodies bind to two different sites of the SARS-CoV-2 spike protein and flag the virus as ‘foreign’, prompting the body’s immune response.
Ronapreve can be administered intravenously for COVID-19 patients in a health care facility and is expected to be targeted for use in unvaccinated people who are at risk of developing severe disease. Treatment with ronapreve has been shown to reduce the risk of hospitalisation and death by up to 70% in patients with confirmed COVID-19.
In addition, the Australian Government has secured access to 500,000 treatment courses of Pfizer’s COVID-19 oral antiviral drug, to be used in combination with the protease inhibitor drug ritonavir, subject to regulatory approval by the TGA.
This treatment which is still undergoing clinical trials is expected to help to reduce the severity or onset of illness in adults who contract, or have been exposed to, COVID-19. It is expected to be available over the course of 2022, subject to final clinical trials being completed by Pfizer and the necessary TGA approval process.
This oral antiviral treatment is taken every 12 hours for five days and is designed to block an enzyme the virus needs in order to multiply early in its lifecycle.
Co-administration with a low dose of ritonavir is expected to help slow the metabolism, or breakdown, of the treatment in order for it to remain active in the body for longer periods of time at higher concentrations to combat the virus.
Ritonavir has been used extensively in combination with other antivirals for other viral diseases to help slow metabolism in a similar way.
On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to this treatment which means that Pfizer can apply to the TGA for approval through this fast track approval process once the clinical trials are complete.
Whilst vaccination remains the best protection against COVID-19 our Government continues work to ensure that Australians have early access to safe and effective treatments as they are made available. These agreements reinforces our strong response to managing COVID-19 outbreaks and ensures that Australia benefits from new pharmaceutical technologies.
As with all COVID-19 treatments, both of these medications will be rigorously assessed by the TGA for safety, quality and effectiveness before it can be 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.
Following regulatory approval by the TGA, Ronapreve will join other COVID-19 treatments including sotrovimab and remdesivir that are already available to health professionals, through the ³Ô¹ÏÍøÕ¾ Medical Stockpile to help treat people with COVID-19.
Australia has also secured an advanced purchase agreement for 300,000 courses of the promising oral COVID-19 treatment Molnupiravir for supply in 2022 subject to TGA approval.
These purchase agreements have been supported by the Science and Industry Technical Advisory Group, which is the Australian Government’s expert group advising on COVID-19 vaccine and treatment purchases.
Further review of the clinical guidelines for use of these treatments in Australia will be undertaken by the ³Ô¹ÏÍøÕ¾ COVID-19 Clinical Evidence Taskforce.
