Washington: The US Food and Drug Administration (FDA) on Wednesday (local time) authorized Pfizer's Paxlovid COVID-19 pill for high-risk people aged 12 and over to treat coronavirus disease (COVID-19).
"The US Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death," US Food and Drug said in a statement.
President Joe Biden said it marks a "significant step forward" on the path out of the pandemic. The pill is a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.
Biden said his administration will work with states to ensure equitable distribution.
"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research.
Cavazzoni added, "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19." Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir's breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days, said the statement.
