Australia’s first COVID-19 treatment approved

Pharma News: The Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead’s remdesivir (Veklury) as the first treatment option for COVID-19. It has received provisional approval for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.

Remdesivir is the most promising treatment option so far to reduce hospitalisation time for those suffering from severe coronavirus infections. Remdesivir will not be available to Australians unless they are severely unwell, requiring oxygen or high level support to breathe, and in hospital care.

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.

On 10 July 2020, Gilead Sciences announced additional data on remdesivir. The data 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 62% reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials.

Gilead’s analyses of the company’s compassionate use program demonstrated that 83% of paediatric patients (n=77) and 92% of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by Day 28. No new safety signals were identified with remdesivir across these populations. To further the understanding of these results in individual patient cases, Gilead recently announced the initiation of a global, open-label Phase 2/3 trial to evaluate the safety, tolerability and pharmacokinetics of remdesivir in paediatric patients from birth to less than 18 years of age. Gilead is also collaborating on a study for pregnant women.

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 the U.S., 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. 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.