December 3, 2023

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EU may not approve Merck COVID-19 oral drug Molnupiravir

EU may not approve Merck COVID-19 oral drug Molnupiravir

EU may not approve Merck COVID-19 oral drug Molnupiravir

According to Endpoints news, the European Medicines Agency (EMA) is likely to reject Merck’s emergency use authorization application for the COVID-19 oral drug Molnupiravir, because the clinical data of Molnupiravir is less satisfactory than other COVID-19 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. It is the world’s first oral antiviral drug approved for the treatment of mild to moderate COVID-19 in adults, and was first approved for marketing in the UK on November 4, 2021.

EU may not approve Merck COVID-19 oral drug Molnupiravir.

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. However, data on all subjects (n=1433), released on November 26, showed a dramatic drop in the drug’s effectiveness, with a 30% reduction in the risk of hospitalization and death.

On November 30, 2021, the US FDA Antimicrobial Drugs Advisory Committee (AMDAC) positively supported the EUA application for Molnupiravir with 13 votes in favor and 10 votes against.

The Advisory Committee believes that the known and potential benefits of Molnupiravir outweigh the known and potential risks of Molnupiravir in high-risk adult patients with mild to moderate COVID-19 within 5 days of treatment symptom onset.

Opponents also listed the following reasons, 1) only analyzing patients enrolled after the interim analysis, the difference in 29-day hospitalization and mortality between the Molnupiravir and placebo groups was small (4.7% vs 6.2%); 2) for the Delta variant 3) Potential mutagenicity, etc.

A person familiar with the EMA 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.S. pharmacies also say they run out of space to store Molnupiravir tablets because few people use it. T

he French health department also said that it decided to cancel the order for 50,000 doses of Molnupiravir due to the unsatisfactory clinical data disclosed by the drug.

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.

Merck disclosed in its 2021 financial report that sales of Molnupiravir in 2022 are expected to be $5 billion to $6 billion. If the drug cannot be approved by the EMA, it may be a big blow to its market performance.

EU may not approve Merck COVID-19 oral drug Molnupiravir

(source:internet, reference only)

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