Remdesivir approved by TGA to treat COVID-19

The Therapeutic Goods Administration (TGA) has granted provisional approval to antiviral drug remdesivir as a treatment option for COVID-19, for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised. This makes it the first medication for the novel coronavirus SARS-Cov-2 to be approved in Australia.

Remdesivir has been described as the most promising treatment option so far to reduce hospitalisation time for those suffering from severe SARS-Cov-2 infections. By reducing recovery times patients will be able to leave hospital earlier, freeing beds for those in need. However, the product has not been shown to prevent coronavirus infection or relieve milder cases of infection. It will thus only be made available to Australians who are severely unwell, requiring oxygen or high-level support to breathe, and in hospital care.

Australia is the 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. Provisional approval, which is limited to a maximum of six years, was made on the basis of preliminary clinical data, as there is the potential for substantial benefit to Australian patients. Remdesivir manufacturer Gilead Sciences may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.

The news comes just over a month after Australia’s National COVID-19 Clinical Evidence Taskforce gave a conditional recommendation for the use of remdesivir to treat people with COVID-19, off the back of two recent clinical trials. Since then, the taskforce has gone on to recommend the use of the anti-inflammatory steroid dexamethasone for the treatment of COVID-19 patients who are receiving oxygen or mechanical ventilation.

To make this latest recommendation, the taskforce reviewed results from the preprint data of the UK RECOVERY trial, which indicated that dexamethasone is the first treatment to reduce mortality in COVID-19. As noted by Taskforce Executive Director Associate Professor Julian Elliott, “The results showed that dexamethasone reduced risk of death by 14% in patients requiring oxygen and by 29% in ventilated patients.

“This treatment could save the lives of patients in Australia who are seriously unwell with COVID-19,” Assoc Prof Elliot continued, noting that dexamethasone is an inexpensive drug that is already available in hospitals around Australia. However, he acknowledged that the results showed no benefit for patients who did not require oxygen and there remains no evidence to suggest the drug prevents people from contracting COVID-19.

Finally, confidence in the controversial malaria drug hydroxychloroquine has waned after the WHO accepted a recommendation to discontinue the hydroxychloroquine and lopinavir/ritonavir arms of its Solidarity trial, established to find an effective COVID-19 treatment for hospitalised patients. The interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalised COVID-19 patients when compared to standard of care.

A research team from the University of Basel and the University Hospital Basel believe they know the reason for the drugs’ apparent ineffectiveness. Having studied lopinavir and hydroxychloroquine concentrations in the plasma of COVID-19 patients, the researchers calculated the corresponding concentration in the lung compartment — the anatomic site of SARS-CoV-2 infection. Their results, published in the journal Antimicrobial Agents and Chemotherapy, strongly suggest that it is unlikely that both drugs reach sufficient concentrations to inhibit the virus replication in the lung.

The WHO’s recent decision applies only to the conduct of the Solidarity trial in hospitalised patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalised patients or as pre- or post-exposure prophylaxis for COVID-19.

Image credit: ©stock.adobe.com/au/Halfpoint

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