New COVID-19 drug nears approval in Australia

Australia’s regulator has taken the first step towards registering a new anti-viral drug for the treatment of COVID-19 in adults.

It has granted a provisional determination for the drug molnupiravir that is said to inhibit replication of the virus in the body. This oral drug, taken as a capsule, is intended for the treatment of mild to moderate COVID-19.

Molnupiravir is considered to have broad-spectrum activity against a range of RNA viruses including SARS-CoV-2, which causes COVID-19.

On Monday, the Therapeutic Goods Administration granted the provisional determination to Merck Sharp & Dohme, known as MSD outside the US and Canada.

This means the company is now eligible to apply for provisional registration on the Australian Register of Therapeutic Goods. Provisional determination is the first step in the process and the TGA anticipates the company will submit an application for provisional registration shortly.

Molnupiravir was developed in 2019 by researchers at Emory University and in partnership with Ridgeback, conducted early experiments that attracted the attention of Merck.

According to Ridgeback’s website, it has completed Phase 1 and Phase 2 studies with molnupiravir and its program has advanced into Phase 3 development of the drug as a therapeutic for COVID-19.

In June, the Biden administration committed to purchasing 1.7 million courses of molnupiravir, should the Food and Drug Administration provide it with Emergency Use Authorisation. The cost of supplying this number of courses would be $US1.2 billion ($1.63 billion).