The Therapeutic Goods Administration (TGA) of Australia has awarded provisional approval for the use of Gilead Sciences’ remdesivir (Veklury) to treat Covid-19 patients, marking the first authorisation of treatment for this disease in the country.
The approval enables the use of the drug in adults and adolescents hospitalised with severe Covid-19 symptoms.
TGA noted that, so far, remdesivir demonstrated the most promise as a treatment option to decrease hospitalisation time for people with coronavirus infections.
The drug is expected to help mitigate the strain on the country’s health care system. A decrease in recovery times will allow patients to leave the hospital earlier, freeing beds for others.
In Australia, remdesivir will be given to patients who suffer from severe illness, need oxygen or high-level support for breathing and in-hospital care, said TGA.
The regulator added that the drug has not been found to prevent Covid-19 infection or alleviate milder cases of infection.
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A statement from TGA said: “Australia is one of the first regulators to authorise the use of remdesivir for the treatment of Covid-19, following on from recent approvals in European Union, Japan, and Singapore.
“International regulatory cooperation played a significant role, as the European Medicines Agency and the Singapore Health Sciences Authority generously shared their review reports with TGA at an early stage.”
The approval comes within two weeks of application submission reviewed by a TGA multidisciplinary review team.
Limited to a maximum of six years, the provisional authorisation comes from preliminary data. Gilead can seek full registration after additional safety and efficacy data required by the TGA are available.
Last week, Mylan obtained regulatory approval from the Drug Controller General of India (DCGI) for restricted emergency use of 100mg/vial remdesivir lyophilised powder to treat Covid-19.