Pfizer says its Covid-19 pill is likely to work against Omicron

Preliminary laboratory tests have shown encouraging signs that

Pfizer Of Inc.

PFE 1.15%

experimental Covid-19 pill The company says those newly infected can work against Omicron.

Pfizer also said Tuesday that a final analysis of late-stage study results confirmed the drug, called Paxlovid, was 89 percent effective at reducing the risk of hospitalization and death in at-risk adults. high risk of severe Covid-19 disease.

The positive results come as the Food and Drug Administration considers whether the use of Paxlovid should be phased out in high-risk adults, a decision that could be made before the end of the year.

“This is a real home run, offering great hope for another highly effective intervention,” Pfizer Chief Science Officer Mikael Dolsten said in an interview.

Meanwhile, a separate preliminary analysis has provided indications that the drug may help people at low risk of severe Covid-19 illness, such as vaccinated people who end up falling ill.

Paxlovid in the original study analysis reduced the risk of hospitalization and death by 70% in adults at low risk for severe Covid-19 illness, although it failed to relieve or resolve their symptoms. within four days.

Study subjects at high risk of developing severe disease must have at least one underlying health condition or characteristic such as obesity or advanced age. Other research included people who were unvaccinated and at low risk of developing severe illness, such as young and healthy people, or vaccinated people who had at least one risk factor for developing severe illness.

Both studies testing Paxlovid in humans showed significantly less viral load, or viral load, in subjects given the drug than in the placebo group, Pfizer said.

A lower viral load can mean less virus transmission.

Citing study results, some analysts say Paxlovid has the potential to become the Covid-19 drug of choice for newly infected adults looking to avoid severe illness. Analysts at JP Morgan Chase & Co. estimated revenue of $18 billion next year.

Shares of Pfizer were mostly unchanged Tuesday morning.

Doctors and medical professionals have been searching for an antiviral like Paxlovid, which people can easily use at home within days of symptoms appearing. prevent their case from getting serious and required hospitalization.

However, the emergence of Omicron has obscured the approach of such antiviral drugs, as it is uncertain whether the new strain can evade treatments and vaccines.

To make their assessment, drug manufacturers studied whether authorized and tested Covid-19 drugs and vaccines could work. Effective against Omicron.

Doctors are increasingly turning to monoclonal antibody drugs to treat patients at high risk for Covid-19. The WSJ looks at how therapies work and why they’re important in saving lives. Illustration: Jacob Reynolds / WSJ

The researchers suspect Pfizer’s pill could stay effective because it blocks the virus by blocking the action of an important enzyme, called protease, that the virus needs to replicate and isn’t thought to be infected. mutation in Omicron.

That’s different from the Covid-19 vaccine and some treatments that target another part of the virus, the mutated protein, where many omicron . mutation.

Initial tests in Pfizer’s lab showed that Paxlovid blocked the protease enzyme in Omicron, as well as other variants of concern, Dr. Dolsten said.

“Without the active protease, the virus cannot replicate and cause disease,” Dr. Dolsten said. “I strongly believe that the effects on Paxlovid’s Omicron will be significant.”

Pfizer says it plans to do more tests to measure Paxlovid’s effectiveness on this variant.

In November, Pfizer said an early look at a key study found Paxlovid is 89% effective reduce the risk of hospitalization and death in high-risk adults.

The FDA is waiting for the final results before making the decision to authorize, Pfizer CEO Albert Bourla said last week at The Wall Street Journal’s Board of CEOs.

In the final analysis, 5 of 697 high-risk subjects who received the drug within 3 days of symptoms were hospitalized or died from Covid-19, compared with 44 of 682 subjects who received placebo. pharmacy, Pfizer said.

The company said nine study volunteers given the placebo died, compared with none in the treatment group.

The researchers also reported that the drug was 88% effective if taken within five days of symptoms.

Final study analysis of another oral antiviral drug, from

Merck

& Have. and partner Ridgeback Biotherapeutics LP, showed a 30% risk reduction, which is lower than the 50% found in the initial period.

Separately, Pfizer tested Paxlovid’s effectiveness in people at low risk of severe illness, including some who had been vaccinated.

The company’s preliminary results showed that Paxlovid was unable to resolve or consistently reduce self-reported symptoms within four days, which was the primary goal of the study and how the antiviral drug was determined. effective or not.

However, two of the 333 low-risk subjects with Paxlovid were hospitalized, compared with eight of 329 subjects given a placebo, a 70 percent outcome, Pfizer said.

No subjects died of Covid-19 in the analysis, which considers how about 45% of the total subjects targeted for the study died.

Dr Dolsten said Pfizer planned to discuss with health authorities in the US and other countries the possibility of making the drug available to people at low risk and whether Pfizer should do more testing. or not.

Write letter for Jared S. Hopkins at jared.hopkins@wsj.com

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Ian Walker

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