FDA Authorizes Oral Antiviral for COVID-19

By Jonathan Springston, Editor, Relias Media

The FDA on Wednesday issued an emergency use authorization (EUA) for Paxlovid, a combination of nirmatrelvir and ritonavir tablets, to treat mild or moderate COVID-19 infections in patients age 12 years and older. This is the first oral solution to treat COVID-19, joining a long list of other drugs and non-vaccine biologicals to receive an FDA EUA during the pandemic.

“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Nirmatrelvir stops SARS-CoV-2 from replicating, while ritonavir slows nirmatrelvir’s breakdown in the body. Paxlovid is three tablets (two of nirmatrelvir, one of ritonavir). Patients take these tablets all at once twice a day for five days. The FDA cautions clinicians to administer Paxlovid as soon as possible after a positive COVID-19 diagnosis. Patients should not take Paxlovid past day 5 of the five-day treatment window, nor should anyone mistake the solution as a substitute for vaccination.

In November, Pfizer, the manufacturer of Paxlovid, made a deal with the Biden administration to provide the federal government with 10 million doses of the solution in phases, starting before the end of 2021 and continuing throughout 2022.

“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with COVID-19,” Xavier Becerra, secretary of the Department of Health and Human Services, said at the time. “Getting vaccinated remains the most important action anyone can take to help protect themselves and others and end this pandemic, but for people who do get sick in the future and are at risk of severe outcomes, having pills they can take to keep them out of the hospital could be a lifesaver.”

The FDA based its EUA on a double-blind, placebo-controlled study of Paxlovid as a treatment for non-hospitalized symptomatic adults with a laboratory-confirmed diagnosis of SARS-CoV-2 infection who had not received a vaccine and had not been infected with COVID-19 previously. Paxlovid reduced the proportion of patients with COVID-19-related hospitalization or death from any cause by 88% vs. placebo among those treated within five days of symptom onset and who did not receive monoclonal antibody therapeutics.

When announcing the deal for 10 million doses of Paxlovid in November, Pfizer Chairman and CEO Albert Bourla said his company was “thrilled” with these trial outcomes. “It is encouraging to see a growing understanding of the valuable role that oral investigational therapies may play in combatting COVID-19, and we look forward to continuing discussions with governments around the world to help ensure broad access for people everywhere,” Bourla added.

For more on this and related subjects, be sure to read the latest issues of Infectious Disease Alert and Internal Medicine Alert. For much more Relias Media coverage of the COVID-19 pandemic, please click here.