Express delivery of oral anti-coronavirus therapy application for emergency use authorization is expected to add new weapons to the fight against the epidemic

▎The content team editor of WuXi AppTec today, Merck & Co.
(MSD) and Ridgeback Biotherapeutics announced that Merck has submitted an emergency use authorization (EUA) application to the US FDA for the oral antiviral therapy molnupiravir under investigation for the treatment of mild to moderate COVID-19 Adult patients, they may be at risk of getting worse or being hospitalized
.

The two companies are also working with regulatory agencies around the world to submit applications for emergency use authorization or listing approval
.

The press release pointed out that if approved, molnupiravir will become the first oral antiviral therapy to treat COVID-19, providing a new weapon for an early end to the epidemic
.

This application is based on the interim analysis results of a phase 3 clinical trial conducted in patients with mild to moderate COVID-19
.

Test results show that molnupiravir reduces the risk of hospitalization or death by approximately 50%
.

After 29 days of treatment, 7.
3% of patients in the molnupiravir group were hospitalized or died, compared with 14.
1% in the placebo group (p=0.
0012)
.

No patients died in the molnupiravir group, while 8 patients died in the control group
.

Related reading: Tribute to Science! The first oral anti-coronavirus therapy is expected to come out.
In terms of safety, the two groups of patients have similar drug-related adverse events (12% and 11%)
.

Fewer patients in the Molnupiravir group stopped treatment due to adverse events (1.
3% and 3.
4%)
.

Image source: Credit-Merck Molnupiravir is a powerful oral ribonucleoside analogue under research that can inhibit the replication of the new coronavirus
.

It was originally developed by scientists at Emory University
.

Merck and Ridgeback Biotherapeutics are currently undergoing phase 3 clinical trials to test its effectiveness and safety in preventing the spread of COVID-19 in the home
.

Mr.
Robert M.
Davis, President and CEO of Merck & Co.
said: "We are very grateful to the patients and researchers who participated in the study
.

At the same time, I also want to pay tribute to my colleagues in the pharmaceutical industry and partners in the global health industry
.

They face the challenge and take the lead.
Drugs and vaccines to fight COVID-19 are here
.

Drugs and vaccines are important tools to fight the epidemic
.

We look forward to working with the FDA and other regulatory agencies to bring molnupiravir to patients around the world as soon as possible
.

"Reference: [1] Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the US FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults.
Retrieved October 11 , 2021, from https:// investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-c/Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

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Views do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views
in the
article .
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.

If you need treatment plan guidance, please go to a regular hospital
.