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Australia Drug Approvals | Drugs approved by TGA

Updated: Jun 26, 2023

September 30, 2022

TGA approved Moderna bivalent vaccine as a booster dose.

The Therapeutic Good Administration granted provisional approval for Moderna's bivalent COVID-19 vaccine as a booster dose. The bivalent vaccine contains original and Omicron BA.4/BA.5 strains and stimulates immunization against the original and Omicron variant.

Moderna can now submit for provisional registration of bivalent vaccine. The company has six months to submit a registration application. Moderna has to offer the clinical trial results for the vaccine's approval.

Previously, Moderna has received provisional approval in Australia for a bivalent vaccine comprising mRNA for the original virus and Omicron BA.1 strain. TGA announced that the bivalent vaccine stimulated a higher immune response against BA.4 and BA.5 variants than the initial Spikevax vaccine.


Feb 23, 2022

Moderna's Spikevax received provisional approval for individuals aged six years and older

The Therapeutic Goods Administration (TGA) in Australia has given provisional approval for Spikevax for individuals aged six years and older. Spikevax is Moderna's COVID 19 vaccine.

TGA has granted provisional approval previously for children aged six to eleven years. The provisional approval is based on the KidCOVE clinical trials, which included 4,000 participants in Canada and the USA. The vaccine demonstrated a similar immune response in children as that in adults.

The Australian Technical Advisory Group on Immunisation (ATAGI) will advise the Government on using the vaccine in the age group.

Jan 28, 2022

Comirnaty received provisional approval in Australia as a booster in 16-17 years old individuals.

The Therapeutic Goods Administration (TGA) has given provisional approval to Comirnaty as a booster dose for individuals aged 16-17 years. Earlier, TGA has given provisional approval as a booster shot for individuals 18 years and older.

The dosage is the same as for adults and should be administered after the two primary doses. Comirnaty received approval as a booster dose in the same age group in the UK, the US, and Israel.

Jan 20, 2022

Novavax, a protein COVID-19 vaccine, is approved provisionally in Australia.

The Therapeutic Goods Administration (TGA) in Australia approved Novovax provisionally, a COVID-19 protein. The drug is included in the Australian Register of Therapeutic Goods (ARTG) to prevent COVID-19 infection in adults 18 years old. The vaccine is under trial in pediatrics and as a booster dose.

Novavax received conditional market authorization in Europe, and WHO has listed it in the emergency use vaccines list.

Australia has agreed to purchase 51 million doses of the Novavax vaccine.

Jan 20, 2022

TGA gave provisional approval to molnupiravir (Lagevrio) and nirmatrelvir + ritonavir (Paxlovid)

The Therapeutic Goods Administration (TGA) approved molnupiravir (Lagevrio) and nirmatrelvir + ritonavir (Paxlovid) for treating adult COVID-19 patients who are at risk of developing severe disease.

Both drugs are recommended twice a day for five days. Lagevrio is available as capsules, and Paxloid is available as tablets. Both drugs are not recommended during pregnancy or breastfeeding.

Paxlovid acts by inhibiting the proteasome inhibitor that prevents virus replication. Both drugs received conditional approval from the MHRA in the UK and FDA.

04 January 2022

AstraZeneca received provisional determination for Evusheld from TGA in Australia

AstraZeneca received a further provisional determination from the Therapeutic Goods Administration (TGA) for Evusheld (ixagevimab and cilgavimab) to prevent and treat COVID-19 in adults and adolescents.

Evusheld consists of two monoclonal antibodies, which bind to the spike protein of the COVID-19 virus, thereby preventing entry into the human cell. This is not an alternative to the COVID-19 vaccines.

This makes AstraZeneca eligible for provisional registration in the Australian Register of Therapeutic Goods (ARTG).

Actemra received provisional approval in Australia to treat COVID-19

In Australia, the Therapeutic Goods Administration has given provisional approval for Actemra (tocilizumab) to treat patients with COVID-19. The drug is approved for treating hospitalized adults who require supplemental oxygen and ventilation.

The efficacy of the drug was determined based on the COVID-19 therapy trial. It is an ongoing trial that determines the effectiveness versus standard of care. Patients enrolled in the trial were divided into three groups; three groups received three different treatment options in the first line. After 21 days of randomization, people were administered either tocilizumab or the usual standard of care (second randomization). 28-day mortality rate after the second randomization was considered as the primary endpoint. The percentage of patients discharged from the hospital was considered as the secondary endpoint.

The 28-day mortality rate was 31% in tocilizumab versus 35% in patients on the usual standard of care. 57% of patients on tocilizumab were discharged from the hospital compared to 50% of patients on the usual standard of care.

Roche’s Rozlytrek approved in Australia for ROS1-positive NSCLC.

Australia’s Therapeutic Goods Administration has approved Rozlytrek (entrectinib) for treating patients suffering from ROS1-positive non-small cell lung cancer.

Rozlytrek acts by inhibiting tropomyosin receptor tyrosine kinase, receptor tyrosine kinase c-ROS oncogene 1 (ROS1; encoded by the gene ROS1), and anaplastic lymphoma kinase enzymes. The drug also inhibits Janus kinase-2 and tyrosine kinase non-receptor 2.

The drug is approved under the black triangle scheme.

The drug was earlier approved in the United States and Japan.

The manufacturer has conducted Phase II STARTRK-2, Phase I STARTRK-1, and Phase I ALKA-372-001 trials and data from the Phase I/II STARTRK-NG study. In ROS1-positive metastatic NSCLC, the tumors shrank in 78% of people, and the duration of response ranged from 1.8 to 38.8+ months.

About ROS1-positive NSCLC

ROS, a tyrosine kinase, is involved in controlling the growth and proliferation of cells. ROS1 gene fusion results in growth and proliferation, which accounts for 1-2% of non-small-cell lung cancer.


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