Aus buys 300K courses of Merck's oral COVID-19 treatment
The Australian Government has made a deal with Merck Sharp & Dohme (MSD) to purchase 300,000 courses of the company’s promising oral COVID-19 treatment, known as molnupiravir, should it receive approval from the Therapeutic Good Administration (TGA).
Originally developed to treat influenza, molnupiravir is an oral antiviral that is currently in late-stage clinical trials for the first-line treatment of COVID-19 in adult patients with mild-to-moderate symptoms. It is a capsule that is taken twice a day for five days — unlike other COVID-19 treatments that require expensive intravenous transfusions — 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.
Treatment with molnupiravir has been shown to stop people with COVID-19 developing serious symptoms, with interim analysis of MSD’s Phase 3 trial showing the treatment reduced the risk of hospitalisation or death in at-risk patients by approximately 50%. At the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration (FDA), recruitment into the study was stopped early due to these positive results.
Minister for Health and Aged Care Greg Hunt said the interim results added to the ongoing analysis the TGA has been undertaking into molnupiravir. He noted, “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.”
On 9 August the TGA granted provisional determination to MSD in relation to molnupiravir, which means MSD is now eligible to apply for provisional registration in Australia; 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.
“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,” Prime Minister Scott Morrison said.
“Vaccines and new treatments like this will boost our National Plan to safely reopen Australia and keep Australia safely open.”
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