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Pfizer (PFE) COVID Pill Paxlovid Gets CHMP Support in Europe
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Pfizer (PFE - Free Report) announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has advised the use of its oral COVID-19 drug, Paxlovid. The drug can be used to treat adult COVID-19 patients who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
The CHMP recommends using Paxlovid as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms.
The CHMP’s advice was issued under a special regulation that will help European Union countries to allow the supply and use of Paxlovid, especially in an emergency situation, even before getting a conditional marketing authorization from the European Commission.. The EMA is presently conducting a rolling review of the marketing application.
The decision to provide early access to Pfizer’s oral pill, which has demonstrated robust effectiveness in clinical studies, was due to a rapid rise in cases, including breakthrough infections, in European countries. The significant infection numbers are again putting a toll on the region’s healthcare systems.
The CHMP’s decision was based on data from an interim analysis of the phase II/III study — EPIC-HR — which showed that Paxlovid reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
Earlier this week, Pfizer announced data from the final analysis of the EPIC-HR study. The results were consistent with the interim data from the study.The data also showed that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo.
We note that Pfizer has already initiated the rolling submission of a regulatory application seeking emergency use authorization (“EUA”) for Paxlovid in the United States. The final data from the EPIC-HR will be shared with the FDA as part of the rolling submission.
Shares of Pfizer gained 4.2% on Dec 16 following the CHMP update. Pfizer’s shares have gained 66.4% so far this year compared with the industry’s increase of 20.2%.
Image Source: Zacks Investment Research
Pfizer’s Paxlovid treatment course includes its SARS-CoV-2 3CL protease inhibitor, PF-07321332, co-administered with a low dose of AbbVie’s (ABBV - Free Report) antiviral drug, ritonavir that is available under the trade name of Norvir. While Pfizer’s PF-07321332 helps in inhibiting the replication of coronavirus, AbbVie’s Norvir helps slow the breakdown of PF-07321332. Co-administration of PF-07321332 with Norvir allows the latter to remain active in the body for longer periods of time at higher concentrations.
AbbVie received first approval for Norvir in 1996 for treating HIV-1 infection in combination with other antiretroviral agents. AbbVie’s Norvir is available in two options — oral solution and oral powder.
We note that another U.S.-based pharma giant, Merck (MRK - Free Report) is also developing an oral COVID-19 pill, molnupiravir, for high-risk, non-hospitalized patients. Merck also filed an EUA application for a COVID pill in November. Last month, FDA’s Antimicrobial Drugs Advisory Committee also voted in favor of authorizing Merck’s molnupiravir.
Final data from Merck’s late-stage study showed that molnupiravir reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19.
In a separate press release, Pfizer and partner BioNTech (BNTX - Free Report) announced the submission of a supplemental biologics license application for their COVID-19 vaccine, Comirnaty. Pfizer and BioNTech are seeking label expansion of their vaccine for use in adolescents aged 12 to 15 years.
We note that Pfizer and BioNTech’s Comirnaty is already approved in the United States for use in individuals aged 16 years and older.
Image: Bigstock
Pfizer (PFE) COVID Pill Paxlovid Gets CHMP Support in Europe
Pfizer (PFE - Free Report) announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has advised the use of its oral COVID-19 drug, Paxlovid. The drug can be used to treat adult COVID-19 patients who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
The CHMP recommends using Paxlovid as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms.
The CHMP’s advice was issued under a special regulation that will help European Union countries to allow the supply and use of Paxlovid, especially in an emergency situation, even before getting a conditional marketing authorization from the European Commission.. The EMA is presently conducting a rolling review of the marketing application.
The decision to provide early access to Pfizer’s oral pill, which has demonstrated robust effectiveness in clinical studies, was due to a rapid rise in cases, including breakthrough infections, in European countries. The significant infection numbers are again putting a toll on the region’s healthcare systems.
The CHMP’s decision was based on data from an interim analysis of the phase II/III study — EPIC-HR — which showed that Paxlovid reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
Earlier this week, Pfizer announced data from the final analysis of the EPIC-HR study. The results were consistent with the interim data from the study.The data also showed that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo.
We note that Pfizer has already initiated the rolling submission of a regulatory application seeking emergency use authorization (“EUA”) for Paxlovid in the United States. The final data from the EPIC-HR will be shared with the FDA as part of the rolling submission.
Shares of Pfizer gained 4.2% on Dec 16 following the CHMP update. Pfizer’s shares have gained 66.4% so far this year compared with the industry’s increase of 20.2%.
Pfizer’s Paxlovid treatment course includes its SARS-CoV-2 3CL protease inhibitor, PF-07321332, co-administered with a low dose of AbbVie’s (ABBV - Free Report) antiviral drug, ritonavir that is available under the trade name of Norvir. While Pfizer’s PF-07321332 helps in inhibiting the replication of coronavirus, AbbVie’s Norvir helps slow the breakdown of PF-07321332. Co-administration of PF-07321332 with Norvir allows the latter to remain active in the body for longer periods of time at higher concentrations.
AbbVie received first approval for Norvir in 1996 for treating HIV-1 infection in combination with other antiretroviral agents. AbbVie’s Norvir is available in two options — oral solution and oral powder.
We note that another U.S.-based pharma giant, Merck (MRK - Free Report) is also developing an oral COVID-19 pill, molnupiravir, for high-risk, non-hospitalized patients. Merck also filed an EUA application for a COVID pill in November. Last month, FDA’s Antimicrobial Drugs Advisory Committee also voted in favor of authorizing Merck’s molnupiravir.
Final data from Merck’s late-stage study showed that molnupiravir reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19.
In a separate press release, Pfizer and partner BioNTech (BNTX - Free Report) announced the submission of a supplemental biologics license application for their COVID-19 vaccine, Comirnaty. Pfizer and BioNTech are seeking label expansion of their vaccine for use in adolescents aged 12 to 15 years.
We note that Pfizer and BioNTech’s Comirnaty is already approved in the United States for use in individuals aged 16 years and older.
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