Merck to Seek EUA for COVID-19 Pill ASAP After ‘Compelling’ Findings
Written by SOURCE on October 1, 2021
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Citing “compelling results” in clinical trials, Merck has announced plans to seek emergency use authorization (EUA) “as soon as possible” for an oral COVID-19 treatment.
The pharmaceutical company and its partner, Ridgeback Biotherapeutics, said Friday that the treatment—an oral antiviral medicine known as molnupiravir—significantly reduced the risk of hospitalization or death. At the interim analysis of a Phase 3 trial in adult patients with mild to moderate COVID-19, the treatment was shown to reduce those risks by approximately 50 percent.
In a statement shared Friday, Merck CEO and president Robert M. Davis said he was “optimistic” about molnupiravir becoming an “important medicine” in the ongoing worldwide effort to bring the pandemic to an end.
“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 health care systems all around the world,” Davis said, adding that the Merck and Ridgeback teams will do everything they can to get the oral antiviral to patients “as quickly as possible.”
Ridgeback CEO Wendy Holman echoed those comments, noting that at-home antiviral treatments are “critically needed” to help in the fight against the pandemic.
“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” Holman said.
Earlier this week, Pfizer shared an update on the status of trials focused on its own oral antiviral candidate, saying its pill is designed to be administered “at the first sign of” infection or exposure.
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