Pfizer files for emergency use authorization with the FDA of its Covid pill that can cut the risk of hospitalization and death by 90%
- Pfizer submitted its application to the FDA for emergency use authorization of its COVID-19 pill on Tuesday
- The pill, called Paxlovid, works by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells
- Clinical trial data showed the drug can cut rates of hospitalization and death from the virus by nearly 90%
- It comes the same day Pfizer signed a deal with the UN-backed group Medicines Patent Pool to let generic drug companies produce the pill for use in 95 nations
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 submitted its application to the FDA for emergency use authorization of its COVID-19 pill on Tuesday (file image)
The pill, called Paxlovid (above), works by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells
Pfizer’s candidate, which is called Paxlovid, belongs to a class of drugs known as protease inhibitors.
The pill would work by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells.
Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.
Earlier this month, the drugmaker released preliminary results of its study of 775 adults who contracted mild-to-moderate COVID-19.
All the participants were unvaccinated and were considered to be at high risk for hospitalization due to underlying conditions including obesity and diabetes.
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.
Just 0.8 percent of patients taking the drug needed to be hospitalized and no one died.
In the comparison group, seven percent were hospitalized and there were seven deaths.
Pfizer did not provide great detail side effects but said rates were about 20 percent in each group.
Pfizer Inc released clinical trial results earlier this month showing its antiviral pill reduced hospitalization and death rates by 89%
Results of the study were so impressive that Pfizer halted it early to seek approval for its usage.
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 has since been greenlit by the UK and is expected to be approved by the FDA during a meeting scheduled on November 30.
It’s unclear how soon the FDA would approve Pfizer’s pill.
Pfizer has also submitted for regulatory approval in Australia, New Zealand and South Korea, and plans to submit applications in more countries.
‘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 FDA on its review of our application, along with other regulatory agencies around the world,’ Bourla said in a news release.
The news comes the same day after Pfizer announced it ha signed a deal with a UN-backed group to let other companies make its COVID-19 pill.
The deal with the Geneva-based Medicines Patent Pool would allow generic drug companies produce the pill so it could be supplied to 95 low- and middle-income countries.
What’s more, Pfizer will not receive royalties on any sales in low-income countries and will waive royalties on sales in all countries covered by the agreement so long as the coronavirus is deemed a public health emergency.