Pfizer formally submits COVID-19 pill to FDA for emergency use authorization
Pfizer has formally asked the Food and Drug Administration to authorize its oral COVID-19 pill for use in high-risk patients, the pharmaceutical giant announced this week.
If granted emergency use authorization (EUA), Paxlovid would become the first oral antiviral of its kind, which could be prescribed at the first sign of infection to avoid severe illness, hospitalization and death.
“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options,” Albert Bourla, CEO of Pfizer, said Nov. 16. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”
The EUA request is based on positive initial results showing adults 18 years and older treated with Paxlovid within three days of showing symptoms experienced an 89% drop in their risk of hospitalization or death.
The treatment course includes taking 30 pills over five days. Patients would take two Paxlovid pills and one antiviral called ritonavir.
The FDA is currently reviewing another COVID-19 pill from Merck & Co. and Ridgeback & Biotherapeutics LP known as molnupiravir that may be cleared for use in the U.S. by years’ end, the Wall Street Journal reports.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.