U.S. health regulators cleared use of a Covid-19 pill from Pfizer Inc., the first drug that newly infected patients can now take at home to stay out of the hospital.
The authorization by the U.S. Food and Drug Administration on Wednesday permits doctors to prescribe the medicine to high-risk patients age 12 and older early in the course of disease, shortly after they develop symptoms.
The FDA said the drug, named Paxlovid, worked safely and would be an important tool in reducing hospital admissions and death.
The pill arrives as the Omicron variant spreads across the U.S. Researchers expect antivirals like Paxlovid would be effective against the new strain because of the way they work, but are waiting for studies to confirm their suspicion.
Paxlovid is expected to be available at pharmacies and hospitals in the coming days. Initial supplies will be limited, until Pfizer can ramp up production.
Pfizer will ship tens of thousands of treatment courses in the U.S. before the end of this year, and hundreds of thousands at the start of 2022, a spokeswoman said. The U.S. government has agreed to pay $5.29 billion to purchase 10 million treatment courses that Pfizer will deliver by the end of next year.
Pfizer said it aims to make 120 million treatment courses next year, up from its previous projection of 80 million.
The pill’s key advantage over most existing treatments is that patients can easily take them at home, unlike antibody therapies or the antiviral Veklury that usually require administration at a clinic or hospital.
“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19,” said Pfizer Chief Executive Albert Bourla.
Pfizer’s pill was found to be more effective than another Covid-19 pill, developed by Merck & Co. and Ridgeback Biotherapeutics LP, in separate studies. The Merck-Ridgeback pill is expected to receive FDA authorization soon.
Paxlovid’s launch puts Pfizer in position to have a commanding presence in the world’s response to the pandemic.
The company’s Covid-19 vaccine, called Comirnaty and developed with BioNTech SE, has become the preferred shot for many countries and is expected to total more than $36 billion in world-wide sales this year.
Paxlovid could reach $18 billion in sales next year, according to JPMorgan Chase & Co. analysts.
Pfizer has said laboratory tests indicate that Paxlovid could work against the Omicron variant, in part because the drug works differently than other therapies targeting the spike protein on the virus.
Researchers designed the pill to stop the coronavirus from spreading in people by blocking activity of a key enzyme, known as protease, which the virus needs to replicate.
The enzyme isn’t believed to be mutated in Omicron, which is why Pfizer and other researchers say the antiviral likely will work against Omicron.
The authorization comes after researchers found Paxlovid was safe and cut the risk of hospitalization or death by about 89% if people at high risk of severe Covid-19 took the pill within three days of diagnosis.
The treatment was also highly effective if begun within five days of symptoms, according to Pfizer.
Some researchers have raised safety concerns, because Paxlovid is taken with another drug. The second drug, called ritonavir, helps Paxlovid fight the virus longer, but can cause side effects when taken with certain widely used heart and cholesterol medicines.
European health regulators, who are reviewing Pfizer’s application for Paxlovid clearance, recently issued preliminary guidelines recommending people don’t use it if they take certain medicines, have severely reduced kidney or liver function, are pregnant or are trying to get pregnant.
Pfizer has said it expects doctors and pharmacists will find most of the drug interactions to be manageable.
Under the authorization, patients age 12 and older should begin a course of treatment within several days of symptoms emerging to prevent their cases from turning serious and requiring hospitalization.
People with a prescription would take two Paxlovid pills and one ritonavir pill twice a day for five days.
Pfizer has a $5.29 billion deal with the U.S. to provide enough supplies to treat 10 million people, with shipments continuing through next year. The company has also licensed Paxlovid’s formula so that generic drugmakers can make it for low- and middle-income countries.
Pfizer is also studying the drug in a separate study in adults at lower risk of developing severe disease, including vaccinated individuals.
Write to Jared S. Hopkins at [email protected]