Drugmaker Pfizer announced on Tuesday that it is seeking emergency use authorization from the Food and Drug Administration (FDA) for its promising oral antiviral treatment for COVID-19.

What You Need To Know

  • Pfizer on Tuesday asked the FDA to authorize its promising oral antiviral treatment for COVID-19

  • If given the green light from U.S. regulators, the pill would be the first of its kind authorized to treat the novel coronavirus

  • Pfizer reported earlier this month that the pill cut hospitalizations and deaths by nearly 90% among high-risk adults

  • Currently, the only authorized treatments to combat COVID-19 are either administered intraveinously or via injection, and are given at a hospital or clinic by a health care professional

If given the green light from U.S. regulators, the pill, known as PAXLOVID, would be the first of its kind authorized to treat the novel coronavirus. 

Pfizer reported earlier this month that the pill cut hospitalizations and deaths by nearly 90% among high-risk adults who had early symptoms of COVID-19. If authorized by the FDA, it could be a major step toward managing the pandemic and returning to normal, offering an easy, effective way for patients people to treat themselves at home.

"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," Pfizer CEO Albert Bourla wrote in a statement. "The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19."

"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," he added.

Currently, the only authorized treatments to combat COVID-19 are either administered intraveinously or via injection, and are given at a hospital or clinic by a health care professional. The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus.

Some experts predict various COVID-19 therapies eventually will be prescribed in combination to better protect against the worst effects of the virus.

The FDA is holding a public meeting later this month where outside experts will scrutinize a competing drug from Merck, before voting on whether to recommend approval. The FDA isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.

Several smaller drugmakers are also expected to seek authorization for their own antiviral pills in coming months.

On Tuesday, Pfizer signed a deal a with U.N.-backed group to allow generic drugmakers to produce low-cost versions of the drug for use in 95 countries, a move that could make the treatment available in more than half of the world’s population.

The Associated Press contributed to this report.