United Kingdom authorizes the use of antiviral Molnupiravir 1:03
(CNN) -
Pharmaceutical Pfizer said Friday that its experimental pill designed to fight the coronavirus reduced the risk of hospitalization and death for high-risk patients participating in a trial of the drug.
The company hopes to eventually offer the pill, administered in combination with an older antiviral drug called ritonavir, for people to take at home before they get sick enough to go to the hospital.
A so-called interim analysis, conducted before the trial was scheduled for completion, showed an 89% reduction in the risk of hospitalization or death from COVID-19 if patients received it early enough, the company said.
Pfizer published the results in a press release and did not provide scientists to discuss the data prior to publication.
The data have not been peer reviewed or published.
The company says it will share more details in a peer-reviewed document and with its submission to the US Food and Drug Administration (FDA).
UK Licenses Merck / Ridgeback Biotherapeutics Antiviral Molnupiravir to Treat Mild to Moderate COVID-19
The company has been testing the drug in adults with COVID-19 who are considered to be at high risk of progressing to serious illness.
Volunteers have been randomly given the combination of pills or a placebo within three to five days of the onset of symptoms.
The pill, still known by its experimental name PF-07321332, is what is known as a protease inhibitor.
It is designed to prevent the virus from multiplying.
Giving it along with ritonavir slows its breakdown in the body, the company said.
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Pfizer said that 0.8% of patients who received the drug combination in three days were hospitalized within four weeks (three of 389 patients) compared with 7% of patients who received placebos, 27 of 385. And seven of those who received placebos died, Pfizer said.
No one who received the treatment died within a month.
"Similar reductions in COVID-19-related hospitalizations or deaths were seen in patients treated within five days of symptom onset; 1% of patients receiving PF-07321332 (with) ritonavir were hospitalized up to the day 28 after randomization (6/607 hospitalized, no deaths), compared to 6.7% of patients who received a placebo, "the company said.
He said 19% of the patients who received the treatment suffered adverse events, compared with 21% who received placebo, but declined to reveal what those adverse events were.
Even if they are infected post-vaccination, vaccinated people do not get as seriously ill with COVID-19, studies show
"These data suggest that our oral antiviral candidate, if approved by regulatory authorities, has the potential to save patients' lives, reduce the severity of covid-19 infections, and eliminate up to nine out of ten hospitalizations," Pfizer CEO Albert Bourla said in a statement.
Currently, remdesivir, sold under the brand name Veklury, is the only antiviral approved by the FDA for the treatment of COVID-19.
It is given by intravenous infusion, so it is not as simple to administer as a pill.
People can also be treated with monoclonal antibodies, which are injected or infused therapies that activate the immune system to help fight infection.
They are not as easy to take as a pill and must be administered by a trained professional.
Merck is seeking emergency use authorization from the FDA for molnupiravir, an antiviral capsule that people can take at home.
It has been shown to reduce the risk of hospitalization or death by approximately 50%.
On Thursday, UK drug regulators licensed molnupiravir under the Lagevrio brand.
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