A worker at Pfizer's manufacturing facility in Freiburg, Germany produces the COVID-19 antiviral pill Paxlovid
A worker at Pfizer's manufacturing facility in Freiburg, Germany produces the COVID-19 antiviral pill PaxlovidPfizer
  • The FDA authorized the first pill to treat COVID-19, a milestone in the fight against the pandemic.
  • The OK comes as Omicron is spreading across the US, causing another surge in cases.
  • The US regulator issued emergency authorization for their use in high-risk people ages 12 and older. 

The Food and Drug Administration has authorized the first pill to treat COVID-19. 

The agency issued an emergency OK on Wednesday for an antiviral developed by Pfizer. The FDA's authorization allows high-risk people age 12 or older to receive the pills. People have to start treatment within five days of showing symptoms. The treatment is given as a five-day regimen consisting of 30 pills. 

"This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Dr. Patrizia Cavazzoni, the director of the FDA's Center for Drug Evaluation and Research said in a statement on Wednesday.

Doctors said they're excited to have an easy-to-use option to treat illness early, before people require hospitalization. The only other drugs currently OK'd to treat non-hospitalized COVID-19 patients are monoclonal antibodies, which are typically delivered by an IV infusion.

The rise of the Omicron variant, which is causing a new wave of cases across the US, has weakened several of those antibody treatments. The variant's mutations render some of those drugs, particularly the ones from Regeneron Pharmaceuticals and Eli Lilly, far less effective in laboratory testing.

Dr. Kavita Patel, a primary-care physician in Washington and former White House health-policy director, said she is eager to start using these pills to treat certain patients, especially because of the logistical challenges with antibody drugs.

"It is just a beast to try to get people monoclonals," Patel told Insider.

Experts also anticipate the antiviral pill will work equally well against Omicron and potential future variants, because the pill don't target the virus' spike protein. The spike protein — used by the virus to latch onto human cells — is the primary target for most vaccines and antibody drugs, and the Omicron variant has more than 30 mutations on that protein.

"Today's authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world," Pfizer CEO Albert Bourla said in a statement.

Pfizer stands to make billions off its new drug

Paxlovid is a new COVID-19 antiviral pill developed by Pfizer
Paxlovid is an antiviral pill to treat COVID-19 developed by PfizerPfizer

The greenlight will trigger a cash windfall for Pfizer, as the US government has signed supply deals in 2021 that were contingent on an FDA authorization.

In November, the US agreed to pay $5.3 billion for 10 million treatment courses of Paxlovid. In a Wednesday press release Pfizer said that it planned to increase total production of the drug from 80 million treatment courses to 120 million courses next year. 

Wall Street analysts expect Pfizer's pill will turn into one of the industry's best-selling medicines in 2022. Analysts at Mizuho and SVB Leerink both forecast Paxlovid sales of $24 billion in 2022.

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