MOSCOW (Pakistan Point News / Sputnik - 20th January, 2022) Australia's Therapeutic Goods Administration (TGA) has granted a tentative approval to two oral medications - Paxlovid and Lagevrio - for use in high-risk patients with mild COVID-19 infection, the agency announced Thursday.
"Both of these products (Paxlovid and Lagevrio), which are the first oral treatments to be approved for COVID-19 in Australia, have been granted provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalization or death," the statement read.
The TGA also advised starting administering either drug as early as possible after diagnosis of COVID-19 and within five days after the onset of symptoms, adding that duration of treatment is five days in both cases.
Lagevrio, commercial name for molnupiravir, inhibits the replication of the coronavirus, while Paxlovid, a combination of two antivirus drugs, nirmatrelvir and ritonavir, blocks a protease enzyme activity needed for coronavirus replication.
The TGA stressed that the provisional approval requires the drug producers to keep providing the data on medications' safety and efficacy in the long run, based on the clinical trials and post-market assessment.
Paxlovid and Lagevrio have already received conditional marketing authorization from regulators in the United Kingdom and the United States, with Paxlovid being approved also in Germany, Canada and South Korea.
According to the TGA, the Australian government has arranged for 500,000 courses of Paxlovid and 300,000 courses of Lagevrio to be available for 2022, with the first batches of drugs expected in the coming weeks.