Infectious Disease

Merck Submits EEA Application for Oral Antiviral Molnupiravir as COVID-19 Treatment

October 11, 2021

Read for 1 minute

ADD SUBJECT TO EMAIL ALERTS

Receive an email when new articles are published on

Please enter your email address to receive an email when new articles are published on . “data-action = subscribe> Subscribe

We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.

Back to Healio

Merck and Ridgeback Biotherapeutics announced that they have filed with the FDA for emergency approval for molnupiravir, an oral antiviral that “inhibits the replication of SARS-CoV-2.”

Treatment is being investigated in adults with mild to moderate COVID-19 who are at risk of progressing to serious illness or hospitalization, according to a press release from Merck. If approved, it could be the first oral antiviral to treat COVID-19, the statement said.

Reference: Press release titled “Merck and Ridgeback’s investigational oral antiviral drug molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo in patients with mild or moderate COVID-19 in a positive interim phase 3 study. ”

“The extraordinary effects of this pandemic require that we act with unprecedented urgency,” Robert M. Davis, CEO and President of Merck said in the press release.

Data from the Phase 3 study released earlier this month by Merck showed that patients receiving molnupiravir were approximately 50% less likely to be hospitalized or contracted from COVID compared to those receiving placebo. 19 to die. The study also showed that molnupiravir appeared to have “consistent efficacy” against SARS-CoV-2 variants.

According to the press release, Merck has already started manufacturing molnupiravir and expects to produce 10 million treatment cycles by the end of the year. The company also has agreements with governments around the world, including the United States, to ensure “timely access” to therapy after regulatory approval, the press release said.

“We look forward to working with the FDA to review our application and working with other regulatory agencies as we do everything in our power to get molnupiravir to patients around the world as soon as possible,” said Davis .

ADD SUBJECT TO EMAIL ALERTS

Receive an email when new articles are published on

Please enter your email address to receive an email when new articles are published on . “data-action = subscribe> Subscribe

We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.

Back to Healio

COVID-19 Resource Center

COVID-19 Resource Center

Related Articles