DORAL, FL – Pfizer pills to treat COVID-19 could get approval from the FDA and become available for the population as the most recent study shows it cuts the risk of hospitalization or death by 89%.
According to a news release from the company, this could be true if given to high-risk adults within a few days of their first symptoms, while if given within the first five days, the efficacy was of 88%.
The study on the experimental pills, that would be offered under the name of Paxlovid for people to take at home before they get sick enough to go to the hospital, found five hospitalizations and no deaths after a month of follow-up among the 697 unvaccinated individuals who received the drug within the first three days of symptoms. Among 682 who received placebo, 44 were hospitalized, including 9 who died.
But Pfizer pills to treat COVID-19 could also benefit those who aren’t at risk if based on another separate study that found Paxlovid may cut hospitalizations in this population. The study includes a mix of unvaccinated adults and vaccinated people with at least one risk factor for severe illness.
Between 20 and 25% of the treatment and placebo groups in each study had adverse mostly mild events. In the study of high-risk adults, people who received the drug were less likely to develop a serious adverse event or stop taking the drug for those reasons.
“This underscores the treatment candidate’s potential to save the lives of patients around the world, whether they have been vaccinated or not,” Pfizer CEO Dr. Albert Bourla said in a statement Tuesday.
“Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”
The latest data on Paxlovid, which combines a new antiviral drug named nirmatrelvir and an older one called ritonavir, was shared by the company with the US Food and Drug Administration seeking for an emergency use authorization but the full study data is still expected to be released later this month and submitted to a peer-reviewed publication. The FDA advisory committee hasn’t set a date yet to make a statement about the treatment.
Other drugs are also on line to get approval from the FDA such as Merck’s molnupiravir but Remdesivir, sold under the brand name Veklury, is the only antiviral (intravenous) authorized by the FDA for treatment of Covid-19.
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