WHO awaiting data from Merck on antiviral drug molnupiravir

Data on phase 3 clinical trial of the investigational antiviral drug released by Merck earlier this month showed that the risk of hospitalisation or death was reduced by 50% in Covid-19 patients with mild to moderate infection as compared to placebo.

The World Health Organization is awaiting full clinical data on oral antiviral medicine molnupiravir developed by Merck & Co Inc for the treatment of coronavirus disease (Covid-19), according to a WHO spokesperson, after the company submitted a request for an emergency use authorization (EUA) to the US drug regulator. On Monday, Merck said in a release that companies are actively working with regulatory agencies worldwide to formally request emergency use or marketing authorization in the coming months.

Merck said 7.3% of patients who received molnupiravir were either hospitalised or died through Day 29 as compared with 14.1% of placebo-treated patients. (Reuters)

"Indeed, this is an interesting development. We would have to see the full data about it. If it holds true, then it is another weapon in the fight against the Covid-19 pandemic," the WHO spokesperson told a UN briefing in Geneva.

Data on phase 3 clinical trial of the investigational antiviral drug released by Merck earlier this month showed that the risk of hospitalisation or death was reduced by 50% in patients with mild to moderate infection as compared to placebo.

The clinical trial evaluated the drug in non-hospitalised adult patients with mild-to-moderate symptoms who were at risk for progressing to severe Covid-19 and hospitalisation.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, chief executive officer and president, Merck, said in a statement.