FDA grants full approval to COVID antiviral Paxlovid for high-risk adults
The Food and Drug Administration granted full approval Thursday to Pfizer's COVID antiviral pill Paxlovid for adults considered at high risk for getting severely ill from COVID-19.
Why it matters: Once considered a "game changer," Paxlovid is the first oral antiviral pill to be approved by the FDA to treat COVID-19 in adults, a few years after the pandemic's outset.
Driving the news: The FDA signaled the treatment has met its "rigorous standards for safety and effectiveness," per Patrizia Cavazzoni, director of the agency's Center for Drug Evaluation and Research.
State of play: The approval could boost uptake of Paxlovid, as many doctors have been hesitant to prescribe the drug, due to concerns about side effects or a belief that a patient is not sick enough.
- The treatment is specifically advised for adults with mild-to-moderate cases COVID who risk ending up in hospital or dying from the virus, including seniors and people with certain medical conditions.
- Full approval from the FDA will allow doctors to have more flexibility when prescribing it to adults with severe COVID symptoms, Reuters reported.
Zoom out: There are longstanding questions about how well the drug works on vaccinated patients or younger people.
- Yet Paxlovid "remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," Cavazzoni said.