Australia's first Covid-19 treatment option, remdesivir, has been approved by the Therapeutic Goods Administration (TGA).
The drug received provisional approval for use in adults with severe Covid-19 symptoms as a promising treatment option to reduce hospitalisation times.
However, it will not be available to everybody, and can only be used in adults and adolescents in hospital with severe infections.
While the approval is a major milestone in Australia's struggle against the pandemic, it has not been shown to prevent coronavirus infection.
Australia is one of the first regulators to authorise the use of remdesivir for treatment following on from recent approvals in the European Union, Japan, and Singapore.
Gilead Sciences said data from a late-stage study showed it significantly improved clinical recovery and reduced the risk of death in Covid-19 patients.
The company said it analysed data from 312 patients treated in a late-stage study and a separate real-world retrospective cohort of 818 patients with similar characteristics and disease severity as in the study.
Findings from the analysis showed that 74.4 percent of remdesivir-treated patients recovered by day 14 versus 59.0 percent of patients receiving standard of care, the company said.
The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at day 14, compared with 12.5 percent among patients not on remdesivir.