Federal government announces agreement for doses of COVID-19 oral antiviral

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MSD has announced that its investigative oral antiviral medicine "significantly reduced" the risk of hospitalisation or death in patients with COVID-19 and the government will announce a deal for around 300,000 doses of the therapy.

MSD is developing molnupiravir as part of a collaboration with Ridgeback Biotherapeutics. The TGA designated molnupiravir for provisional approval in August.

According to an interim analysis of the Phase 3 MOVe-OUT trial in at-risk, non-hospitalised adult patients with mild-to-moderate COVID-19, molnupiravir reduced the risk of hospitalisation or death by approximately 50 per cent.

MSD said 7.3 per cent of patients who received molnupiravir were either hospitalised or died through day 29, compared with 14.1 per cent of placebo-treated patients.

Recruitment into the study has been halted early due to the interim analysis and the company said it plans to submit an application to the US FDA for 'Emergency Use Authorization'.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world," said Robert Davis, CEP and president of MSD.

The federal government has announced a major advance purchase agreement for around 300,000 doses of the oral therapy, contingent on TGA approval.

The company has been producing the therapy at risk and says it expects to produce 10 million courses of treatment by the end of 2021. It already has an agreement to supply the US with 1.7 million courses of treatment and has confirmed "supply and purchase agreements for molnupiravir with other governments worldwide." It has also entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate its availability in more than 100 low-and middle-income countries.