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Source: https://www.cidrap.umn.edu/news-per...gulators-speed-review-covid-19-antiviral-drug
European regulators to speed review of COVID-19 antiviral drug
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Oct 25, 2021
The European Medicines Agency said today that it has started a rolling review of molnupiravir, an oral antiviral drug developed by Merck and Ridgeback Biotherapeutics for treating newly diagnosed COVID-19 in adults.
In a statement, the EMA said its decision to start the assessment is based on preliminary findings that suggest the drug may reduce SARS-CoV-2 replication, which could play a role in preventing hospitalization and death.
The agency notes that a rolling review—a tool used to speed assessment during public health emergencies—will continue until the companies have enough evidence to submit a formal authorization application.
The development follow's Merck's Oct 11 announcement that it and Ridgeback had submitted an emergency use authorization (EUA) application for molnupiravir to the US Food and Drug Administration, which will discuss the data in a Nov 30 meeting of its Antimicrobial Drugs Advisory Committee.
More global headlines
European regulators to speed review of COVID-19 antiviral drug
Filed Under:
COVID-19
Lisa Schnirring | News Editor | CIDRAP News
| Oct 25, 2021
The European Medicines Agency said today that it has started a rolling review of molnupiravir, an oral antiviral drug developed by Merck and Ridgeback Biotherapeutics for treating newly diagnosed COVID-19 in adults.
In a statement, the EMA said its decision to start the assessment is based on preliminary findings that suggest the drug may reduce SARS-CoV-2 replication, which could play a role in preventing hospitalization and death.
The agency notes that a rolling review—a tool used to speed assessment during public health emergencies—will continue until the companies have enough evidence to submit a formal authorization application.
The development follow's Merck's Oct 11 announcement that it and Ridgeback had submitted an emergency use authorization (EUA) application for molnupiravir to the US Food and Drug Administration, which will discuss the data in a Nov 30 meeting of its Antimicrobial Drugs Advisory Committee.
More global headlines
- Parts of Russia, especially Moscow, continue to tighten COVID-19 measures, as the country today reported another daily record high for cases, with 37,930 cases as well as 1,069 more deaths, according to Reuters.
- Germany reported its highest COVID-19 incidence since the middle of May, hitting a threshold that would usually trigger restrictions. The country's health minister, however, said Germany's rising vaccination levels puts it in a better position than during the last spike and restrictions for unvaccinated people would remain in place until next spring.
- South Korea today unveiled a draft plan to gradually ease restrictions, based on rising vaccination levels, according to Yonhap News. So far, about 70% of eligible people are fully vaccinated. The three-part plan begins on Nov 1 with the removal of operating-hour curbs on cafes and restaurants. Officials will also introduce a vaccine pass that would require vaccination or a negative test result for entry to multiuse places.
- The global total today reached 243,899,478 cases, and 4,952,235 people have died from their infections, according to the Johns Hopkins online dashboard.