Australia’s TGA approves remdesivir while Gilead reports reduced mortality risk

Posted by

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. 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.

The expansion of remdesivir’s global use has been supported by the recent announcement of Gilead Sciences on additional remdesivir clinical data at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) that includes a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, 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.

Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.

“We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of COVID-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women.”

One comment

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.