This is the first oral antiviral to get through the regulatory process and is indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
This morning, the FDA approved the oral antiviral pill, Paxlovid (nirmatrelvir/ritonavir), for treatment of mild-to-moderate COVID-19 for adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” said Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research.
This approval is part of a public health strategy that has transitioned towards minimizing COVID-19 infections rather than fully preventing them.
Vaccines, for example, can be used to prevent severity.
“The benefit of vaccination continues to be it is very good protection against severe disease, hospitalization, and death,” Carlos Del Rio, MD, interim dean, Emory University School of Medicine and interim chief, Academic Office for Emory Healthcare, said in a recent interview with Contagion. “Vaccines are not very good at preventing infections, especially with the current variants. There’s been a significant amount of immune escape.”
As COVID-19 undergoes a transformation that is settling into an endemic phase, clinicians and the public will need to accept the fact people will continue to contract the virus.
For those people that do, antivirals are available. “For people over the age of 65 and have mild or moderate COVID, the use of antivirals, like Paxlovid, are frequently indicated,” Del Rio says. “People might say, ‘I don’t have severe symptoms so I don’t need treatment.’ And we need to remind people to get treated, not because they have severe symptoms or not, but they have risk factors for severe disease.”
The Infectious Diseases Society of America (IDSA) recently updated its existing recommendation on the use of nirmatrelvir/ritonavir for patients with mild-to-moderate COVID-19 at high risk for progression to severe disease.
“In ambulatory patients with mild-to-moderate COVID-19 at high risk for progression to severe disease, the IDSA guideline panel suggests nirmatrelvir/ritonavir initiated within five days of symptom onset rather than no nirmatrelvir/ritonavir,” the authors wrote.
Back in March, the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor of approving a New Drug Application (NDA) for Paxlovid.
Since December 22, 2021, Paxlovid has been available under Emergency Use Authorization (EUA).
Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the US Department of Health and Human Services will continue to be available for treatment of eligible children ages 12-18 who are not covered by today’s approval, the FDA said in its announcement.