On 9 August 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.
This oral antiviral monotherapy will be considered for treatment of COVID-19 in adults.
Molnupiravir is considered to have broad-spectrum activity against a range of RNA viruses including SARS-CoV-2, which causes COVID-19. Molnupiravir works by inhibiting replication of SARS-CoV-2.
The granting of a provisional determination means that the TGA has made a decision that MSD is now eligible to apply for provisional registration for Molnupiravir in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that MSD will submit an application for provisional registration shortly.
