The European Medicines Agency (EMA) will consider launching a rolling review of Merck's experimental COVID-19 pill given its promising results submitted by the company, Marco Cavaleri, EMA's head of vaccine strategy, said on Tuesday
MOSCOW (Pakistan Point News / Sputnik - 05th October, 2021) The European Medicines Agency (EMA) will consider launching a rolling review of Merck's experimental COVID-19 pill given its promising results submitted by the company, Marco Cavaleri, EMA's head of vaccine strategy, said on Tuesday.
"We will be considering whether to start a rolling review for this compound in the next days. And of course, the idea is to understand if the data supports such rolling review and whether we could come up in a timely manner with an opinion on the use of this product," Dr. Cavaleri said during EMA regular press briefing on COVID-19.
Molnupiravir, which would be the first oral antiviral medication for COVID-19 if it gets regulatory approval, reduces by half the risks of dying or being hospitalized for people most at risk of contracting severe COVID-19, according to the developer.
Merck has tracked 775 high-risk adults with mild-to-moderate COVID-19. Out of those, 7.5% patients taking molnupiravir showed severe enough symptoms to be hospitalized within 30 days, compared to 14.1% of those who got the dummy pill that were then hospitalized or died. Over the study period, no deaths were registered among those who received the drug, compared with eight in the placebo group.
Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report the results in the coming months.
