The US Food and Drug Administration approved Paxlovid, an antiviral drug that treats mild to moderate Covid-19 among adults who are at risk of severe infection.
Paxlovid was available in the United States for adults and teenagers under an emergency use authorisation, or EUA. This restricted the prescription of the drug.
The FDA's full approval standards are more stringent than the EUA.
In a press release, Dr. Patrizia Cazzazzoni, Director of the FDA Center for Drug Evaluation and Research said, "Today's approval demonstrates Paxlovid's safety and efficacy, and that Paxlovid remains an important option for those at high-risk for progression to severe COVID-19 including those who have prior immunity."
The full approval of the drug will allow doctors to use it in a more flexible manner. They may prescribe a longer treatment if the patient shows signs of a recurrence, also known as rebound.
FDA states that Paxlovid is only to be used for Covid-19. The FDA says that Paxlovid should only be used for Covid-19.
Paxlovid combines two medications, nirmatrelvir (as a pill) and ritonavir (as a liquid), which must be taken for five consecutive days in the first five days after a person experiences Covid-19 symptoms.
Paxlovid, in the clinical trials leading to the approval of the medication, reduced the risk hospitalization or death of patients who were at high risk of severe disease due to their age or underlying health conditions by 86% when compared with a placebo.
According to the FDA, Paxlovid was the first and fourth pill approved by the FDA for treating Covid-19.
Some people find it difficult to take this medication because of its interactions with other medications. It will be marked with a warning on the black box about possible interactions with other medications.
The FDA has said that the FDA will continue to approve the emergency use of the drug for adolescents aged 12-18, despite the fact that the FDA only approved the treatment for adults today.