The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the Pfizer antiviral pill to treat Covid-19 along with caution for people with certain pre-existing conditions foreshadowing a new era for the future, over-the-counter treatment of the deadly respiratory disease that has killed millions.
According to the reports, Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved for the treatment of mild-to-moderate coronavirus disease (Covid-19) in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 testing. The pill has also been approved for those at high risk for progression to severe Covid-19, including hospitalisation or death.
Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research stated that the authorisation 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. This authorisation 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.
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