On Friday, drug company Pfizer announced results from an interim analysis reportedly showing its new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.
In an announcement, the company stated:
- PAXLOVID™ […] was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
- In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
- Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. [Food and Drug Administration] for Emergency Use Authorization (EUA) as soon as possible
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. 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,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”
“All of us at Pfizer are incredibly proud of our scientists, who designed and developed this molecule, working with the utmost urgency to help lessen the impact of this devastating disease on patients and their communities,” said Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “We’re thankful to all of the patients, investigators, and sites around the world who participated in this clinical trial, all with the common goal of bringing forth a breakthrough oral therapy to help combat COVID-19.”
As the BBC reported, “The drug – Paxlovid – is intended for use soon after symptoms develop in people at high risk of severe disease.”
The company also noted that, per “the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA),” it ended more enrollment into its study because of “the overwhelming efficacy demonstrated in these results …”
On Friday, President Biden said, “If authorized by the FDA we may soon have pills that treat the virus in those who become infected,” noting, “We’ve already secured millions of doses. The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”
The BBC reported on Friday, “The UK has already ordered 250,000 courses of the new Pfizer treatment, which has not yet been approved, along with another 480,000 courses of MSD’s molnupiravir pill.”
Britain became the first country in the world to approve the COVID-19 pill by the company Merck earlier this week.
As reported by Reuters:
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
“The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days,” The Associated Press reported.
The country is the first in the world to approve use of the drug, which could potentially lead to other nations doing the same.
As reported by The Daily Wire, Merck stated last month that the company, as well as Ridgeback Biotherapeutics, asked for emergency authorization from the U.S. Food and Drug Administration (FDA) for the molnupiravir pill.
“Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization,” Merck announced in a press release. “The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.”
The Daily Wire noted that the appeal was based on “positive results from a planned interim analysis” which “evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization.” Per the interim analysis, “molnupiravir reduced the risk of hospitalization or death by approximately 50%.”
The FDA reportedly stated in October that a group of independent specialists would look into the effects and safety of the drug later this month.
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