THE Therapeutic Goods Administration (TGA) has approved the provisional registration of Gilead Sciences' Veklury (remdesivir) for the treatment of adults and adolescents with COVID-19.
In the Australian Public Assessment Report for Remdesivir, the TGA said "the decision to approve this medicine has been made based on limited data", adding Gilead would be required to enter into "extensive post-market commitments".
The provisional registration period for remdesivir is two years from 10 Jul 2020, when it received the Australian Register of Therapeutic Goods (ARTG) certificate of registration.
In the absence of comprehensive study reports for any Phase III trials the TGA said, provisional registration was the most appropriate regulatory option.
"Given the urgent public health need during the COVID-19 pandemic, the TGA Delegate proposes to register Veklury (remdesivir) via the provisional pathway," the report said.
"The provisional registration reflects the present deficiencies of the data balanced with the public health need."
Remdesivir will also be included in the TGA's Black Triangle Scheme, which provides a simple means for health practitioners and patients to identify certain types of prescription medicines, including those being used in new ways to encourage the reporting of adverse events associated with their use.
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