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News Article

Merck to Request Emergency Use Authorization for COVID-19 Pill

By Antonio Gozain | Fri, 10/01/2021 - 16:49

Molnupiravir, an experimental antiviral pill developed by Merck, halves the chances of dying or being hospitalized for severe COVID-19 illness, interim clinical trials suggest, highlighting the drug as a potential innovation in how the virus is treated.

The interim analysis, which included 775 patients, indicated that 7.3 percent of those given molnupiravir were hospitalized, compared with 14.1 percent of patients who were given a placebo. While there were no deaths in the molnupiravir group, eight patients who were given a placebo during the trial later died of COVID-19.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families and societies and strain healthcare systems all around the world. With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” said Merck through a press release.

Following the positive results of the study, which are yet to be peer-reviewed according to BBC, Merck plans to request emergency approval for molnupiravir, which would become the first COVID-19 oral antiviral medication.

"Merck plans to submit an application for Emergency Use Authorization (EUA) to the US FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide,” said Merck trough a press release.

Merck is not the only drugmaker preparing to request EUA for an antiviral pill. Pfizer ran a successful second-stage trial of a similar pill earlier in September, as reported by MBN. “We believe that, if successful and authorized or approved, these investigational therapies could provide end-to-end treatment options for COVID-19 patients, including those exposed to the virus, those with diagnosed infections treated in the outpatient setting, and those hospitalized with moderate to severe infection,” reads Pfizer’s webpage.

Unlike COVID-19 vaccines, which target the spike protein on the outside of the virus, molnupiravir’s treatment targets an enzyme that the virus uses to copy itself. Both Pfizer’s and Merck’s drugs are designed to prevent the virus from multiplying. While Pfizer’s blocks the activity of a key enzyme that helps the virus replicate, Merck’s pill introduces errors into the RNA of SARS-CoV-2.

Both US drugmakers have a long history in the Mexican market. Merck has over 90 years of experience in the country and currently works on the healthcare sector, life and science and electronics. Pfizer arrived in 1951 and opened a production plant in 1958. The Pfizer/BioNTech COVID-19 vaccine is more popular in the west and one of the most used in Mexico. It was also  the first of the nine jabs authorized for emergency use by COFEPRIS along with Sinopharm, AstraZeneca, CanSino Biologics, Sputnik V, Sinovac, Covaxin, Johnson & Johnson and Moderna.

The data used in this article was sourced from:  
MBN, Merck, BBC, Reuters, Pfizer
Antonio Gozain Antonio Gozain Journalist and Industry Analyst