TGA approves remdesivir (Veklury®)

In a media release published on 10 July, the Therapeutic Goods Administration (TGA) announced the new treatment drug remdesivir (Veklury®) is now available exclusively for patients with COVID-19 who are severely unwell, requiring oxygen or high level support to breathe and in hospital care.

Australia is one of the first countries in the world to review this medication and make it available to patients in critical need. “TGA’s approval was able to be made within 2 weeks of the receipt of the submission with a large multidisciplinary review team at TGA working around the clock.”

“Remdesivir is the most promising treatment option so far to reduce hospitalisation time for those suffering from severe coronavirus infections. Remdesivir offers the potential to reduce the strain on Australia’s health care system. By reducing recovery times patients will be able to leave hospital earlier, freeing beds for those in need.”

Also on 10 July, the pharmaceutical company behind the development of remdesiver, Gilead Sciences Pty Ltd, published a global media release Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19. The additional data shows that “Remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials.”

Due to the urgency of the COVID-19 pandemic, Gilead Sciences is sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir.

As the clinical data is still in the preliminary stages, the TGA has issued provisional approval for remdesivir and limited this to a maximum of six years. “The sponsor, Gilead Sciences Pty Ltd may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.”

“While this is a major milestone in Australia’s struggle against the pandemic, it is important to emphasise that the product has not been shown to prevent coronavirus infection or relieve milder cases of infection.”

For updates on the current Federal Government COVID-19 resources and restrictions, see the following websites:

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