The US Food and Drug Administration (FDA) on Thursday granted a full approval to Pfizer‘S Paxlovidan antiviral treatment for COVID-19 for adults at high risk of developing severe illness.
The original pill is authorized for emergency use in the United States by the end of 2021.
The decision comes more than two months after an advisory panel of the health regulator voted in favor of full licensing of the drug.
The data presented by both the FDA and Pfizer during the advisory meeting helped alleviate safety concerns surrounding the potential for a recurrence of Covid-19 symptoms following a five-day course of Paxlovid.
Pfizer can now sell Paxlovid, which includes two oral drugs – ritonavir and nirmatrelvir – at commercial prices on the private market in the United States.
The approval will also give doctors more flexibility in prescribing the drug to adults with severe symptoms of COVID-19.
The original pill is authorized for emergency use in the United States by the end of 2021.
The decision comes more than two months after an advisory panel of the health regulator voted in favor of full licensing of the drug.
The data presented by both the FDA and Pfizer during the advisory meeting helped alleviate safety concerns surrounding the potential for a recurrence of Covid-19 symptoms following a five-day course of Paxlovid.
Pfizer can now sell Paxlovid, which includes two oral drugs – ritonavir and nirmatrelvir – at commercial prices on the private market in the United States.
The approval will also give doctors more flexibility in prescribing the drug to adults with severe symptoms of COVID-19.
