FDA says Merck's anti-COVID-19 pill is effective, but more study needed for use in pregnant people

Merck antiviral
Posted at 9:21 AM, Nov 26, 2021

The FDA said Friday that Merck's anti-COVID-19 pill is effective in treating the virus but said that regulators will meet next week to investigate whether the pill is safe for people who are pregnant to take.

The pill, known as molnupiravir, is on track to become the first approved COVID-19 treatment that does not require a shot or an IV.

The pill, which is intended to be taken twice a day for five days by people with mild or moderate COVID-19, has been shown in trials to cut down on hospitalizations and deaths in adult patients who have contracted the virus. The pill also reduces hospitalization and death among those who have risk factors associated with poor disease outcomes.

After the company released clinical trial results earlier this month, White House medical adviser Dr. Anthony Fauci said the data on the drug was promising.

"There was a 50% diminution of importance, is that in the placebo group there were eight deaths and in the treatment group, there were no deaths. That's also very important and very good news," Fauci said.

The federal government has already purchased 1.7 million doses of Merck's drug with the option to purchase more.

"If approved, I think the right way to think about this is, this is a potential additional tool in our toolbox to protect people from the worst outcomes of COVID," White House COVID-19 response team coordinator Jeff Zients said last week. "But I think it's really important to remember that vaccination remains far and away our best tool against COVID-19. It can prevent you from getting COVID in the first place, and we want to prevent infections, not just wait to treat them once they happen."

Merck has also already signed an agreement with the U.N.-backed Medicines Patent Pool to allow other drugmakers to produce the pill, which will help increase supply worldwide upon approval.