FDA authorizes second COVID-19 pill, from Merck
The Food and Drug Administration (FDA) on Thursday authorized a COVID-19 treatment from Merck, marking the second pill to become available to fight the virus.
This authorization is more limited than one on Wednesday for a Pfizer pill. The FDA authorized the Merck pill, developed with Ridgeback Biotherapeutics, for high-risk adults “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
That is, if other options are not available, the Merck pill can be used.
That limitation reflects that the Pfizer pill has demonstrated significantly stronger results in trials. The Pfizer pill was shown to reduce the risk of hospitalization or death in high-risk patients by 89 percent, while the Merck pill had a 30 percent reduction.
The Merck pill is expected to be in greater supply early on, though. The White House said Wednesday that 3 million courses of the Merck pill would be available in January, compared to 265,000 for Pfizer.
“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” she added.
There are also concerns that the Merck drug could cause birth defects if used during pregnancy, so the FDA said the drug is not recommended for use during pregnancy.
Like the Pfizer pill, the Merck pill is also intended to be used within five days of symptoms beginning. That poses some logistical challenges, given that testing will need to be widely available enough that people can get their results back and seek the treatment from a health care provider within five days.
The Biden administration has touted the treatments as a new tool in the fight against the virus.
“From day one, our strategy has been to fill the nation’s medicine cabinet with a diverse set of options to treat people,” Jeff Zients, White House COVID-19 response coordinator, said on Wednesday.
This story was updated at 10:11 a.m.