Two New Oral COVID-19 Pills Provisionally Approved in Australia

The logo of the Therapeutic Goods Administration is seen at a COVID-19 vaccines press conference in Canberra, Australia, on May 6, 2021. AAP Image/Lukas Coch

Australia’s medicines regulator, the Therapeutic Goods Authority (TGA), has provisionally approved two oral medications to treat COVID-19, the disease caused by the novel coronavirus—Paxlovid by Pfizer and Lagevrio by Merck Sharp and Dohme.

They are the first oral treatments for COVID-19 to be approved for adults in Australia who do not need oxygen therapy, but “who are at increased risk of progression to hospitalisation or death,” the TGA said in a release on Thursday.

The TGA has recommended that either drug, both of which need a prescription and are taken twice a day for five days, should be administered as soon as possible after diagnosis and within five days of the onset of symptoms.

While Lagevrio is available in capsules, Paxlovid consists of two separate tablets, nirmatrelvir and ritonavir.

Lagevrio inhibits replication of the SARS-CoV-2 virus, and it is not recommended during pregnancy and breastfeeding. Whereas the nirmatrelvir component of Paxlovid blocks protease enzyme activity which is essential for coronavirus replication.

Nirmatrelvir is given in combination with low-dose ritonavir to maintain plasma levels of nirmatrelvir throughout the treatment.

Paxlovid is also not recommended in pregnancy or breastfeeding, nor in women of childbearing potential.

In addition, Paxlovid is contraindicated for patients with greatly reduced kidney or liver function, and may cause adverse reactions if taken with some commonly used medicines which are included in the product information.

Health Minister Greg Hunt said in a release on Thursday the clinical trials of Lagevrio and Paxlovid show that they reduce the risk of hospitalisation or death in COVID-19 patients who are at a high risk of severe disease.

“We are working to target access to those most vulnerable including the elderly and those in aged care through the National Medical Stockpile (NMS) with the view to transition to the Pharmaceutical Benefits Scheme (PBS) arrangements as supply continues to grow,” he said.

Meanwhile, despite a number of other drugs available world-wide to treat COVID-19, they remain unavailable for treatment of patients in Australia—this includes ivermectin, doxycycline, hydroxychloroquine, and other off-label use medications.

The TGA has already approved a number of treatments for COVID-19, and is currently evaluating three more—molnupiravir, an antiviral treatment that comes in tablet form; a treatment called PF-07321332, which will be used in combination with ritonavir; and tixagevimab and cilgavimab (Evusheld), a treatment consisting of two monoclonal antibodies.