Pfizer Inc submitted an application with the U.S. Food and Drug Administration for emergency use authorization of its COVID-19 pill on Tuesday.
Recent clinical trial data found the drug can can cut rates of hospitalization and death from the virus by nearly 90 percent.
Additionally, it may become an important tool in cities and countries that have limited access to vaccines or low vaccination rates.
Pfizer CEO Albert Bourla had said earlier today that the company planned to submit data to the FDA before Thanksgiving.
Pfizer filed a request to FDA for the emergency use authorization of COVID-19 on Tuesday (file image)
Pfizer’s candidate for PF-07321332, also known as PF-07321332, falls under the umbrella of protease inhibitors.
It would block an enzyme used by the coronavirus to create copies inside of human cells.
According to the company, protease inhibitors were effective in treating HIV and Hepatitis C viruses as well, and can be used alone or together with other antivirals.
This month the drugmaker announced preliminary findings from its study on 775 people who had mild-to-moderate cases of COVID-19.
The participants had not been vaccinated. They were also considered high-risk for hospitalization from underlying diseases such as diabetes and obesity.
Pfizer Inc. released preliminary results from a clinical trial on Friday that showed its antiviral pills reduced death and hospitalization rates by 89%
The patients were treated within three to five days of reporting their first symptoms and for a total of five days.
Patients taking Pfizer’s drug along with an antiviral HIV medication saw an 89 percent reduced risk of hospitalization or death after a month compared to the placebo group.
Only 0.8 percent required hospitalization for the medication, and none of them died.
Seven percent of the hospitalized in comparison were admitted, and seven people died.
Pfizer didn’t provide much information on side effects, but stated that rates in both groups were around 20 percent.
The study’s results were so compelling that Pfizer stopped it before approval was given.
This is the second pill to prove effective at treating the disease after Merck & Co announced last month that its experimental antiviral could reduce the risk of serious illness and death by half.
Merck’s pill was approved by the UK, and will be reviewed by FDA at a November 30 meeting.
The FDA is yet to approve Pfizer’s Pill.
This news item is current and will be updated.