Pharmaceutical Pfizer Inc. says an oral drug to treat COVID-19 could be available by the end of 2021.
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Pfizer The final analysis of the antiviral Covid-19 pill still showed nearly 90% effectiveness in preventing hospitalization and death in high-risk patients, and lab data said on Tuesday the final analysis of the antiviral Covid-19 pill still showed. recently showed that the drug remains effective against the fast-spreading omicron variant of the coronavirus.
Last month, the U.S. drugmaker said the oral drug was about 89 percent effective at preventing hospitalization or death when compared with a placebo based on interim results in about 1,200 people. The data disclosed on Tuesday included an additional 1,000 people.
No one in the Pfizer-treated trial died, compared with 12 deaths in those who received the placebo.
Pfizer is given with the older antiviral ritonavir every 12 hours for five days, starting soon after the onset of symptoms. If authorized, the treatment will be sold as Paxlovid.
Pfizer also released initial data from a second clinical trial showing that the treatment reduced hospital admissions by about 70% in about 600 standard-risk adults.
“It’s an amazing result,” Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.
“We’re talking about an incredible number of lives saved and hospital admissions averted,” said Dolsten. “And of course, if you roll this out quickly after the infection, we have a lot of money. potentially significantly reducing transmission,” said Dolsten.
Dolsten said he hopes to soon get approval from the U.S. Food and Drug Administration and other regulators for use by people at high risk. He doesn’t believe an FDA advisory board meeting will be needed.
“We are engaged in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulators globally,” said Dolsten.
There is currently no authorized oral antiviral treatment for Covid in the United States.
Competitor Merck requested an emergency use authorization for the antiviral drug molnupiravir. But that drug only reduced hospitalization and death rates in the clinical trial in high-risk patients by about 30%.
Some scientists have also raised safety concerns about Merck’s potential for birth defects, as well as concerns that it could cause the virus to mutate.
Pfizer’s drug works differently. It is part of a class of drugs called protease inhibitors that are currently used to treat HIV, hepatitis C, and other viruses.
Dolsten said recent laboratory testing showing the protease activity of the omicron variant is “as good as essentially any SARS-COV-2 variant of interest.”
The company says it may have 180,000 treatments ready to ship this year and plans to produce at least 80 million more by 2022.
Dolsten said Pfizer is looking to expand that production even further because new variants, like the newly discovered omicron, could push demand for the antiviral essentially higher. Current vaccines appear to be less effective at preventing omicron infections.
Pfizer, the company that produces one of the leading Covid-19 vaccines with a German partner BioNTech, has agreed to allow generic drug manufacturers to supply versions of the drug to 95 low- and middle-income countries through a licensing agreement with the international public health group Medicines Patent Pool (MPP). . However, Dolsten said next year he expects the drug to be primarily made by Pfizer.
The US government has secured 10 million packs of Pfizer drugs worth $5.29 billion.