Topline
Pfizer on Thursday announced it is seeking full Food and Drug Administration approval for its oral Covid-19 antiviral Paxlovid, an anticipated move that could boost confidence in the drug and sets the stage for the company to market directly to consumers.
Pfizer is seeking full FDA approval for Paxlovid
Key Facts
Pfizer said it was seeking the FDA’s full approval for Paxlovid for use in vaccinated and unvaccinated people at risk of severe Covid-19.
Paxlovid is only available under an emergency use authorization (EUA) at the moment, which limits who Pfizer can sell the drug to, restricts advertising and communications on the drug and only allows it to remain on the market during an emergency.
Pfizer’s application is broadly in line with how Paxlovid is used under its EUA, which the company said covers an estimated 50% to 60% of the population who have at least one risk factor for severe illness that would make them eligible like diabetes or obesity.
Final results from the company’s clinical trial found that Paxlovid cut the risk of hospitalization or death by 86% when taken within five days of symptoms starting.
Pfizer chairman and chief executive Albert Bourla said data shows Paxlovid is an “important treatment option” for patients at risk of severe disease “regardless of vaccination status.”
Key Background
Paxlovid is one of the only oral antiviral drugs approved for Covid-19. Its development was hailed as a game-changer in the fight against the pandemic, plugging a crucial gap that existed between caring for those seriously unwell in hospital and preventing illness in the first place through vaccination. In April, the White House pushed for wider use of the lifesaving drug after officials complained the drug was still underused even though initial supply issues had been overcome. Experts and officials are investigating reports of “rebound” infections when taking Paxlovid and testing negative, effectively a recurrence of symptoms and testing positive after the initial reprieve. The Centers for Disease Control, alongside experts like Dr. Anthony Fauci (who experienced a rebound infection in June), stressed this could be a natural part of the Covid infection in some people, regardless of treatment or vaccination status.
Big Number
1.6 million. That’s how many courses of Paxlovid have been administered across the U.S. since it was cleared for emergency use in December, according to data from the Department of Health and Human Services.
Further Reading
Source: https://www.forbes.com/sites/roberthart/2022/06/30/pfizer-seeks-full-fda-approval-for-covid-antiviral-pill-paxlovid/