The TGA has approved remdesivir for treatment of severe coronavirus infections
The Therapeutic Goods Administration (TGA) has granted provisional approval to remdesivir (Veklury) as the first treatment option for COVID-19 in Australia, for use in adults and adolescent patients with severe symptoms who have been hospitalised.
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.
International regulatory cooperation played a significant role, says the TGA, as the European Medicines Agency and the Singapore Health Sciences Authority shared their review reports with Australian regulators at an early stage.
TGA’s approval was able to be made within two weeks of the receipt of the submission, with a large multidisciplinary review team at TGA “working around the clock”.
Provisional approval, which is limited to a maximum of six years, was made on the basis of preliminary clinical data, which revealed potential for substantial benefit to Australian patients.
The sponsor, 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.
Remdesivir is an antiviral medicine that interferes with the production of viral RNA, preventing the virus from multiplying inside cells, explains the European Medicines Agency.
“Remdesivir is the most promising treatment option so far to reduce hospitalisation time for those suffering from severe coronavirus infections,” says the TGA.
“[It] offers the potential to reduce the strain on Australia’s healthcare system. By reducing recovery times patients will be able to leave hospital earlier, freeing beds for those in need.”
However the TGA emphasised that while the decision is a “major milestone” in Australia’s struggle against the pandemic, the product has not been shown to prevent coronavirus infection or relieve milder cases of infection.
The drug will not be available to Australians unless they are severely unwell, requiring oxygen or high level support to breathe, and in hospital care.
The TGA recommendation is significant, said Australia’s Deputy Chief Medical Officer Dr Nick Coatsworth.
“Remdesivir has already been given to patients in Australia, both earlier on in the pandemic and in recent weeks in Victoria. That drug is available, that’s good news for people who are suffering from moderate to severe coronavirus disease,” said Dr Coatsworth.
The important thing to note about any of these medications of course is that none of them as yet are a silver bullet.
“None of the international trials that have been conducted involving remdesivir have shown marked results, but they have shown some results that indicate that it might be effective in patients with moderate to severe coronavirus disease.
“They include a reduction in the length of hospital stay and a potential reduction in the serious adverse events that coronavirus sufferers can get during their episode of coronavirus disease. Both of those things may be an indicator of positive effect, what we don’t know yet is if it has a conclusive effect on mortality.”
Treatment with remdesivir comprises one of two trial arms in the World Health Organization’s Solidarity trial, with the second arm looking at lopinavir/ritonavir with interferon beta-1a.
The WHO recently discontinued the hydroxychloroquine and lopinavir/ritonavir-only arms after evidence from interim results showed the two drugs produce little or no reduction in the mortality of hospitalised COVID-19 patients when compared to standard of care.
Meanwhile remdesivir was previously tested as an Ebola treatment and has reportedly generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses.
Preliminary results from a double-blind, randomised, placebo-controlled trial of intravenous remdesivir in adults hospitalised with COVID-19, published in the New England Journal of Medicine in May, found the drug was superior to placebo in shortening time to recovery in adults hospitalised with COVID-19 and evidence of lower respiratory tract infection.