Merck seeks EUA for COVID-19 antiviral treatment

After promising result in clinical trials, the company has submitted data to regulatory bodies across the globe.

Drugmaker Merck and Ridgeback Biotherapeutics are seeking to add another tool to fight the ongoing COVID-19 pandemic.

According to a news release, the company has submitted an application for emergency use authorization to the Food and Drug Administration and other global regulatory bodies for the investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.

As previously reported, a planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, CEO and president of Merck, says in the release. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients. I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts. We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries.

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On Aug. 23, the FDA fully approved the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval.

Late last month the Centers for Disease Control and Prevention (CDC) recommended booster shots of the Pfizer COVID-19 vaccine Comirnaty for those over 65 and those at high risk of severe COVID-19 due to an underlying condition. CDC Director Rochelle Walensky went a step further and recommended the extra shots for those in high-risk occupations or institutions.

Specifically, the CDC recommends boosters for:

  • people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
  • people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.