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Pharmaceutical giant Pfizer announced Friday that its antiviral COVID-19 pill, when administered in conjunction with a widely used HIV drug, cut the risk of hospitalization or death by 89 percent in virus patients. The preliminary results from the trial were so positive that an independent board of experts recommended that the study be halted so that the drug can be offered to the general public sooner, the drugmaker said.
The company will submit the data “as soon as possible” to the Food and Drug Administration to seek emergency authorization for the pill. “Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer CEO Albert Bourla said in a statement. “These data suggest that our oral antiviral candidate, if approved or authorized 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.”
The pill is the second of its kind, after Merck last month submitted data to the FDA and asked the agency for an emergency authorization of its pill, called molnupiravir. But based on the preliminary data, Pfizer’s pill appears to be even more effective than Merck’s. Both the Pfizer and Merck pills are intended mostly for high-risk patients, who are older or have comorbidities that make them more likely to become severely sick from COVID-19. Right now, Gilead’s remdesivir, sold under the brand name Veklury, is the only antiviral approved for the treatment of COVID-19 by the FDA, but it’s given by intravenous infusion and is costly. An easy-to-administer pill could broaden access.
Pfizer said the data on its pill, which will be sold under the brand name Paxlovid, comes from a trial of 1,219 patients who had an underlying medical condition and a laboratory-confirmed infection within a five-day period. Half of the patients were given the experimental pill within three days of symptom onset and compared with patients who received a placebo treatment. Pfizer announced the data in a press release and has not yet published the underlying data so that it can be reviewed by independent scientists.
The company will submit the data “as soon as possible” to the Food and Drug Administration to seek emergency authorization for the pill. “Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer CEO Albert Bourla said in a statement. “These data suggest that our oral antiviral candidate, if approved or authorized 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.”
The pill is the second of its kind, after Merck last month submitted data to the FDA and asked the agency for an emergency authorization of its pill, called molnupiravir. But based on the preliminary data, Pfizer’s pill appears to be even more effective than Merck’s. Both the Pfizer and Merck pills are intended mostly for high-risk patients, who are older or have comorbidities that make them more likely to become severely sick from COVID-19. Right now, Gilead’s remdesivir, sold under the brand name Veklury, is the only antiviral approved for the treatment of COVID-19 by the FDA, but it’s given by intravenous infusion and is costly. An easy-to-administer pill could broaden access.
Pfizer said the data on its pill, which will be sold under the brand name Paxlovid, comes from a trial of 1,219 patients who had an underlying medical condition and a laboratory-confirmed infection within a five-day period. Half of the patients were given the experimental pill within three days of symptom onset and compared with patients who received a placebo treatment. Pfizer announced the data in a press release and has not yet published the underlying data so that it can be reviewed by independent scientists.
