Foreign media: EU may not approve Merck's new crown oral drug molnupiravir

Article source: Medical Cube Info

Author: info

According to Endpoints news, the European Medicines Agency (EMA) is likely to reject Merck's emergency use authorization application for the new crown oral drug molnupiravir, because the clinical data of molnupiravir is less satisfactory than other new crown drugs
.

Molnupiravir is a nucleoside analog discovered by DRIVE (Drug Innovations at Emory), a non-profit organization affiliated to Emory University.
Its activity in inhibiting SARS-CoV-2 replication is 3-10 times higher than that of Redcivir.
Activity has been shown in preclinical models of SARS-CoV-2 viral infection prevention, treatment, and transmission prevention
.

On December 23, 2021, Molnupiravir received emergency use authorization from the U.
S.
Food and Drug Administration (FDA) for the treatment of adult patients with mild to moderate COVID-19
.

On October 1, 2021, Merck announced the interim results of the Phase III clinical study of Molnupiravir, which reduced the risk of hospitalization and death by 50% in non-hospitalized patients
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On November 30, 2021, the U.
S.
FDA Antimicrobial Drugs Advisory Committee (AMDAC) positively supported the EUA application for Molnupiravir with 13 votes in favor and 10 votes against
.

A person familiar with the EMA's approval process once told The New York Times that the drug was "a little disappointing" and that the 30 percent efficacy "started to approach the limit of (perceived) benefit.

" Some U.

It is reported that before the use of molnupiravir, people were prescribed Pfizer's oral drug Paxlovid and GSK/Vir neutralizing antibody sotrovimab at the same time, which makes molnupiravir basically a third-line treatment drug
.