The FDA appears poised to approve the use of both Pfizer’s and Merck’s COVID-19 pills. Learn how the new medicines will affect treatment for the coronavirus.
The FDA will likely announce the approval of Pfizer’s Paxlovid pill, developed to treat infections of COVID-19, as well as a competing pill from Merck. Bloomberg reported the news Tuesday morning, citing “people familiar with the matter” who asked not to be identified.
Last week Pfizer announced that Paxlovid, its proposed COVID-19 oral medication, reduces the risk of hospitalization or death by 89% if administered within three days of symptoms.
If given within five days, the pill still reduced the risk of severe reaction by 88%, according to final study results. That’s up from the 85% efficacy rate reported in an interim analysis in November.
If approved by the Food and Drug Administration, the drug “could have a meaningful impact on the lives of many,” Pfizer CEO 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 … We are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”
Paxlovid, which would fight the more severe symptoms of COVID-19, would be added to the arsenal of tools doctors have to battle the pandemic, along with the approved COVID vaccines from Moderna, Pfizer, and Johnson & Johnson.
What is Pfizer’s COVID-19 antiviral drug?
In the US, the three approved COVID vaccines can prevent infection. But for those already infected, antiviral drugs could reduce the odds of serious symptoms, hospitalization, and death.
Nirmatrelvir, marketed under the brand name Paxlovid, is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. In clinical trials, taken in combination with ritonavir, a drug used to treat HIV, Paxlovid reduced the risk of hospitalization or death by 89% when taken within three days of symptoms, Pfizer said. (The ritonavir allows the medication to remain active in the body longer at higher concentrations.)
If the Paxlovid is approved, two 150mg tablets would be administered at the first sign of symptoms or a positive COVID-19 test result and continued over a five-day treatment course.
The pill has proven effective against COVID-19 variants of concern, including delta and the newer omicron strain, Pfizer said.
During clinical trials, reported side effects between those taking Paxlovid and those taking a placebo were about the same, according to the pharmaceutical company.
Pfizer Inc. (PFE) said that it will supply the United Kingdom an additional 2.5 million treatment courses of its investigational candidate PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).
It is in addition to the 250,000 treatment courses previously contracted by the UK Government, pending authorization and recommendation for use, bringing the full amount of treatment courses to 2.75 million.
Pfizer expects to produce PAXLOVID up to 80 million courses of treatment by the end of 2022, with 30 million treatment courses available in the first half of the year.
If authorized or approved, Pfizer will offer oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe. High and upper-middle-income countries will pay more than lower-income countries.
Pfizer noted that it continues to invest up to about $1 billion to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options. It has entered into agreements with multiple countries and has initiated bilateral outreach to approximately 100 countries around the world.
If authorized or approved, PAXLOVID will be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.
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