Pfizer (NYSE: PFE) announced Tuesday that its experimental antiviral pill developed as a COVID treatment reduced both hospitalizations and deaths among patients at high risk of severe illness, according to the company's final data analysis.
The pill, planned to be marketed as PAXLOVID, cut hospitalizations and deaths by 89% when taken three or five days of symptom onset, the company said, reinforcing the pill's preliminary analysis published back in November. The pill is administered alongside a common antiviral, ritonavir, every 12 hours for five days. In the trial, no patient given the treatment died, compared to 12 deaths among placebo recipients. Moreover, preliminary studies in laboratory settings suggest that the antiviral may protect against the new, highly mutated Omicron variant.
"This news provides further corroboration that our oral antiviral candidate, if authorized or approved [by the U.S. Food and Drug Administration (FDA) as well as the U.S. Centers for Disease Control and Prevention], could have a meaningful impact on the lives of many, as the data further support the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load," said CEO Albert Bourla in a press statement. "This underscores the treatment candidate's potential to save lives of patients around the world."
"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," Bourla added.
Additionally, Pfizer released early data from a second ongoing clinical trial suggesting that the treatment reduced hospitalization rates by about 70% in around 600 adult participants that are at standard-risk of severe disease.
There are currently no oral antiviral treatments for COVID authorized or approved for use in the United States.
In addition to Pfizer, Merck (NYSE: MRK) has asked the FDA for an emergency use authorization for its antiviral pill, molnupiavir, with clinical trial data suggesting that the pill reduces hospitalizations and death by about 30% in high-risk patients. However, some scientists have raised concerns that Merck's pill has the potential to cause birth defects and could further mutate the COVID virus, Reuters reports.
Pfizer's pill works differently than Merck's, with the antiviral being a part of a class of drugs called protease inhibitors, which are commonly used to treat HIV, hepatitis C as well as other viruses.
Pfizer said it can have 180,000 treatment courses ready to ship this year, and expects to produce at least 80 million courses in 2022. The U.S. government has secured 10 million courses from Pfizer in a $5.29 billion deal.