Pfizer gears up for Paxlovid new drug application submission to FDA

The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year.

Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the EPIC-SR study.

In a press release describing the gathering of new data to support a new drug application submission, Pfizer noted that EPIC-SR data from standard-risk vaccinated and unvaccinated patients were not statistically significant but underscored its efficacy overall.

In the EPIC-SR study, the drug passed the statistically significant threshold of reducing COVID-19-related medical visits per day compared to placebo by 62%. In addition, the study found a non-significant 70% relative risk reduction for the key secondary endpoint of hospitalization or death.…

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Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic 

Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus.

The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after exposure to a household contact.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) led to risk reductions of 32% at day five of therapy. That figure climbed to 37% at day ten of treatment.

The study was completed during the omicron wave.

The emergency use authorization for the drug calls for the drug to be administered twice daily for five days.

Paxlovid appeared to be well tolerated across the EPIC-PEP study and the related EPIC-HR and EPIC-SR trials. In addition, Pfizer noted that the post-market safety data were also encouraging.

The st…

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The Biden administration vows to increase COVID-19 antiviral supplies

Photo by Tabrez Syed on Unsplash

White House officials have a plan to ramp up the availability of Pfizer’s COVID-19 antiviral Paxlovid, according to a report from Bloomberg.

White House Covid-19 Response Coordinator Dr. Ashish Jha said that the administration would announce more details about the plans to make Paxlovid more widely available in the coming week.

The administration plans to launch a test-to-treat initiative that allows recently diagnosed COVID-19 patients to receive Paxlovid at no cost.

CVS, Walgreens and Walmart plan on participating in the program.

According to White House officials, the use of oral antivirals increased 103% between March 27 and April 10.

Anecdotal evidence from a handful of patients suggests that Paxlovid also may help relieve so-called long COVID-19 symptoms, according to Reuters. However, more data are needed to confirm the drug’s efficacy in re…

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Manufacturers ink deal to make generic version of Pfizer’s oral COVID-19 pill Paxlovid

The Medicines Patent Pool (MPP) announced that it has signed agreements with 35 manufacturers to make an inexpensive version of Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir/ritonavir) to be distributed in 95 low- and middle-income countries.

Vaccination rates in many developing countries lag far behind that of wealthier countries. In Nigeria, for instance, 9.1% of the population has received at least one dose, whereas 77% of those in the U.S. are partially or fully vaccinated.

The U.S. pays roughly $530 for a course of Paxlovid.

Pfizer has previously stressed its goal of providing equitable access to COVID-19 therapies worldwide. In November 2021, the company entered a deal with MPP to ensure the availability of Paxlovid to low- and middle-income countries.

“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,”…

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President Biden vows to make aggressive use of Pfizer’s COVID-19 antiviral 

President Joe Biden [Image courtesy of the White House]President Biden said in his State of the Union address that the U.S. aims to ramp up the use of Pfizer‘s (NYSE:PFE) Plaxovid.

The treatment has been in short supply since it won emergency use authorization late last year.

Last year, when Merck & Co. (NYSE: MRK) and Pfizer were close to winning regulatory authorization for COVID-19 antivirals, many pundits hailed the treatments as a potential gamechanger.

To date, however, the use of antivirals has been limited, although demand has been especially high for Pfizer’s Paxlovid antiviral.

Get the full story from our sister site, Pharmaceutical Processing World. 

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President Biden vows to make aggressive use of Pfizer’s COVID-19 antiviral 

President Joe Biden [Image courtesy of the White House]

President Biden aims to ramp up the use of Pfizer‘s (NYSE:PFE) Plaxovid, even though the treatment has been in short supply.

Last year, when Merck & Co. (NYSE: MRK) and Pfizer were close to winning regulatory authorization for COVID-19 antivirals, many pundits hailed the treatments as a potential gamechanger.

To date, however, the use of antivirals has been limited although demand has been especially high for Pfizer’s Paxlovid antiviral. Demand for Merck’s molnupiravir has been weak, as a recent article from NPR explains.

Now, Biden’s plan calls for providing the antiviral at no cost immediately after individuals receive a positive COVID-19 test result.

Available under emergency use authorization (EUA), Paxlovid is indicated to treat mild-to-moderate COVID-19 in individuals at least 12 years old who weigh …

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Pfizer’s Paxlovid wins positive opinion from CHMP 

The Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer’s (NYSE:PFE) COVID-19 pill be granted conditional marketing authorization.

Specifically, CHMP recommended that the antiviral, comprising PF-07321332 and ritonavir, be used in adults not requiring supplemental oxygen who face an elevated risk of severe COVID-19.

If the European Commission signs off on the drug, it could be the first oral antiviral available in the region.

The organization provided guidance on the potential use of the drug in December.

To reach its recent recommendation, CHMP scrutinized clinical data from a study demonstrating the drug significantly reduced the risk of hospitalization or death in patients at risk of developing severe COVID-19. That study found that 0.8% of Plaxovid recipients required more than 24 hours of hospitalization compared to 6.3% of those who got placebo. There were no deaths in the Plaxovid group, which comprised 1,039 p…

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Pfizer’s Paxlovid holds up to omicron in studies

Pfizer (NYSE:PFE) revealed that its COVID-19 drug Paxlovid retained in vitro efficacy against the omicron SARS-CoV-2 variant.

The company said that the research indicates that the drug can potentially maintain plasma concentrates “many-fold” times higher than the level needed to prevent replication of the highly transmissible variant.

“These data suggest that our oral COVID-19 therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern,” said Dr. Mikael Dolsten, chief scientific officer at Pfizer, in a statement.

Demand for Paxlovid, which FDA authorized in late December, has far exceeded supply.

In January, the White House announced that the federal government would buy 20 million courses of Paxlovid — twice as much as initially planned.

Paxlovid combines two antivirals — nirmatrelvir and ritonavir.

In November 2021, Pfizer also announced a license agreement w…

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US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid 

As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid. 

The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing severe COVID-19. 

Biden also vowed that it had offered Pfizer additional resources to accelerate the manufacture of the drug. 

The federal government is ready to use the Defense Production Act to spur quicker production of the drug.  

Pfizer plans on providing roughly 10 million treatment courses to the government by the end of June. It plans on providing the additional 10 million courses by September 30. 

Pfizer has previously announced that Paxlovid had an efficacy rate of 89% in a study focused on its potential to reduce hospitalization or death from COVID-19. The Phase 3 study involv…

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COVID-19 oral antiviral molnupiravir wins FDA nod

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801). 

In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir. 

FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir). 

FDA’s authorization of molnupiravir covers its use to treat mild-to-moderate COVID-19 in individuals at least 18 “who are at high-risk for progression to severe COVID-19.” The authorization constrains the use of the drug to individuals who cannot feasibly use other authorized COVID-19 treatments. FDA does not recommend the medication for patients who are hospitalized with COVID-19. 

The authorization does not support the use of molnupiravir as pre-exposure or post-exposure prophylaxis for COVID-19.

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Pfizer’s COVID-19 antiviral pill could be poised for European regulatory authorization

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid.

CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease.

CHMP also stressed the importance of administering Paxlovid as soon as possible after a COVID-19 diagnosis to boost efficacy.

The guidance, which proceeds marketing authorization, could inform health officials’ planning efforts for Paxlovid.

“The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with COVID-19,” said Albert Bourla, Pfizer CEO, in a press release. “If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring th…

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Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

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